Generated by All in One SEO v4.9.6.2, this is an llms.txt file, used by LLMs to index the site. # Celerion ## Sitemaps - [XML Sitemap](https://www.celerion.com/sitemap.xml): Contains all public & indexable URLs for this website. ## Posts - [The Resurgence of Antibody Drug Conjugates: How ADCs are taking over oncology (again) and what we’ve learned about creating bioanalytical methods to support preclinical and clinical success.](https://www.celerion.com/blog/the-resurgence-of-antibody-drug-conjugates-how-adcs-are-taking-over-oncology-again-and-what-weve-learned-about-creating-bioanalytical-methods-to-support-preclinical-and-clinical-success/) - Michelle Miller, PhD, Global Senior Scientific Director, Bioanalytical Services What is an ADC? Antibody Drug Conjugates (ADCs) consist of a monoclonal antibody linked to a cytotoxic payload. The antibody binds to a cancer antigen, resulting in the targeted delivery of the payload to the tumor site. This potent approach to immunotherapy is often referred to - [Celerion Welcomes Dr. Steven Evans as Senior Cardiologist to Enhance Cardiovascular Safety in Clinical Trials](https://www.celerion.com/blog/celerion-welcomes-dr-steven-evans-as-senior-cardiologist-to-enhance-cardiovascular-safety-in-clinical-trials/) - LINCOLN, Neb.; Nov. 20, 2025 (Business Wire) – Celerion, a global leader in early-stage clinical research, announced the appointment of Dr. Steven Evans as Senior Cardiologist. In his new role, Dr. Evans will strengthen the company’s commitment to participant safety and data integrity by providing expert cardiovascular oversight. Dr. Evans’ responsibilities will be central to - [Celerion Launches Enhanced Version of Labnotes Bioanalytical Data Management Software ](https://www.celerion.com/blog/celerion-launches-enhanced-version-of-labnotes-bioanalytical-data-management-software/) - LINCOLN, Neb.; May 6, 2025 (Business Wire) – Celerion, a global leader in early clinical research and bioanalytical services, announced the launch of the latest version of Labnotes, its cutting-edge bioanalytical electronic laboratory notebook software, elevating data handling and analysis capabilities for sponsors. The latest system enhancements streamline laboratory documentation and improve operational efficiency for - [Celerion Earns AAHRPP Full Reaccreditation for Five Years, Strengthening Commitment to Ethical Research Practices](https://www.celerion.com/blog/celerion-earns-aahrpp-full-reaccreditation-for-five-years-strengthening-commitment-to-ethical-research-practices/) - LINCOLN, Neb.; Oct 9, 2025 (Business Wire) – Celerion, a leader in early clinical research, proudly announces its achievement of a full AAHRPP (Association for the Accreditation of Human Research Protection Programs) reaccreditation for five years by the Council on Accreditation of AAHRPP. Celerion is the only CRO headquartered in the USA to hold this distinguished accreditation. - [PBMCs or Whole Blood? Strategic Applications in Phase I Studies](https://www.celerion.com/blog/pbmcs-or-whole-blood-strategic-applications-in-phase-i-studies/) - Studying peripheral blood mononuclear cells (PBMCs) reveals cell-specific biomarkers—like target engagement and receptor occupancy—that improve decision-making in Phase I clinical trials. This makes these assays incredibly powerful tools in early-phase studies and has resulted in a growing trend of incorporating PBMC isolation and flow cytometry in Phase I clinical studies. PBMCs are a group of white - [The Rising Tide of Weight Reduction Therapies](https://www.celerion.com/blog/the-rising-tide-of-weight-reduction-therapies/) - Sabina Paglialunga, PhD Senior Director, Scientific Affairs Weight reduction drugs are making a big splash! Since glucagon-like peptide 1 (GLP-1) receptor agonists were first approved for weight loss in 2021, there has been an estimated 700% increase in prescriptions in the US.1 This has led to a wave of new GLP-1 and incretin products entering - [Rethinking Drug Development: The Role of Model-Informed Approaches in Advancing Cell and Gene Therapies Without Animal Testing](https://www.celerion.com/blog/rethinking-drug-development-the-role-of-model-informed-approaches-in-advancing-cell-and-gene-therapies-without-animal-testing/) - By Johannes Stanta, PhD, Global Scientific Director, Celerion Inc. As drug development continues to evolve, few areas are advancing as disruptively as cell and gene therapies (CGTs). These highly complex and often personalized treatments are redefining what is possible in modern medicine. But while the science has leapt forward, many of the tools and assumptions - [Smarter, Faster, Safer: Celerion Unveils Major Upgrade to LabNotes Bioanalytical Software](https://www.celerion.com/blog/smarter-faster-safer-celerion-unveils-major-upgrade-to-labnotes-bioanalytical-software/) - At Celerion, we believe that innovation in the lab shouldn’t come at the cost of simplicity or security. That’s why we’re excited to announce the latest evolution of LabNotes, our bioanalytical electronic laboratory notebook (ELN) software designed to make data management more intuitive and more powerful than ever before. Whether you're managing massive datasets or - [FDA Endorses Human-Relevant Nonclinical Models: A Welcome Shift for Monoclonal Antibody Development](https://www.celerion.com/blog/fda-endorses-human-relevant-nonclinical-models-a-welcome-shift-for-monoclonal-antibody-development/) - by Johannes Stanta, PhD – Global Scientific Director, Sabina Paglialunga, PhD – Senior Scientific Director, and Aernout Van Haarst, PhD - Senior Scientific Director The FDA’s recent decision to support non-animal methods for the safety evaluation of monoclonal antibodies (mAbs) is a significant—and long overdue—step forward in modernizing drug development. While the scientific community has - [Ruling the Future: How the ACLA’s LDT Court Victory and Europe’s IVDR Are Shaping Bioanalytical Laboratories](https://www.celerion.com/blog/ruling-the-future-how-the-aclas-ldt-court-victory-and-europes-ivdr-are-shaping-bioanalytical-laboratories/) - by Chad Briscoe, Executive Vice President, Global Bioanalytical Services, Celerion Someone whom I’ve worked with in the past and have had an opportunity to mentor in the bioanalytical field for some time recently asked me about the U.S. federal court ruling on LDTs. I realized I don’t really understand it as well as I would - [Reframing the Definition of Obesity](https://www.celerion.com/blog/reframing-the-definition-of-obesity/) - Sabina Paglialunga, PhD Senior Director, Scientific Affairs Two notable guidance documents addressing obesity and weight loss were issued in January 2025. Surprisingly, they have differing opinions on the role body mass index (BMI) plays in the definition of obesity and the clinical management of patients with obesity. The two documents in question are: The Lancet - [Celerion Expands UK Phase 1 Clinical Research Operations With New Agreement to Relocate to Queen’s University Belfast’s iREACH Health – Clinical Research Innovation Center ](https://www.celerion.com/blog/celerion-expands-uk-phase-1-clinical-research-operations-with-new-agreement-to-relocate-to-queens-university-belfasts-ireach-health-clinical-research-innovation-center/) - LINCOLN, Neb.; Feb. 19, 2025 (Business Wire) – Celerion, a global leader in early clinical research, proudly announces a new agreement to relocate its U.K. Phase 1 clinical research operations to iREACH Health. This state-of-the-art clinical research center, led by Queen’s University Belfast, in partnership with the Belfast Health and Social Care Trust, is set - [Celerion Pledges Commitment to the Science-Based Targets Initiative (SBTi) Net-Zero Standard](https://www.celerion.com/blog/celerion-pledges-commitment-to-the-science-based-targets-initiative-sbti-net-zero-standard/) - LINCOLN, Neb.; Dec. 4, 2024 (Business Wire) – Celerion, a global leader in early clinical research, is proud to announce its commitment to the Science-Based Targets Initiative (SBTi), reinforcing its dedication to sustainable corporate climate action. By aligning with the SBTi and its ambitious goals, Celerion aims to set both Near Term and Net Zero company-wide - [GLP-1 Agonist-Induced Delayed Gastric Emptying – A Clinical Pharmacology Perspective](https://www.celerion.com/blog/glp-1-agonist-induced-delayed-gastric-emptying-a-clinical-pharmacology-perspective/) - By Sabina Paglialunga, PhD & Aernout van Haarst, PhD Senior Directors Scientific Affairs Glucagon-Like Peptide-1 (GLP-1) receptor agonists first came to the market in 2005 as a type 2 diabetes mellitus treatment, and they have been making headlines again for their weight reduction effects. Specifically, semaglutide and tirzepatide, along with diet and exercise, are indicated - [How Healthy Volunteer Studies can Accelerate Oncology Drug Development](https://www.celerion.com/blog/how-healthy-volunteer-studies-can-accelerate-oncology-drug-development/) - By Sabina Paglialunga, PhD & Aernout van Haarst, PhD; Senior Directors Scientific Affairs, Celerion Traditional drugs to treat cancer include chemotherapies, which are cytotoxic agents that non-specifically interrupt cell growth. While chemotherapy drugs effectively obstruct tumor development and growth, they also affect healthy cells, which can result in serious side effects as well as additional - [Celerion’s US Pharmacies Expand On-Site Services, Ensure cGMP FDA Compliance for Phase 1 Investigational Drugs](https://www.celerion.com/blog/celerions-us-pharmacies-expand-on-site-services-ensure-cgmp-fda-compliance-for-phase-1-investigational-drugs/) - LINCOLN, Neb.; July 17, 2024 (Business Wire) – Celerion, a leading clinical research organization specializing in early clinical research and bioanalytical services, announces the launch of on-site services for rapid sterility testing (validated alternative method to USP ) and dose formulation analysis. Per FDA guidance, pharmaceutical products intended for parenteral administration must undergo sterility testing and provide - [Celerion Honored With Prestigious CRO Leadership Award for Ninth Consecutive Year ](https://www.celerion.com/blog/celerion-honored-with-prestigious-cro-leadership-award-for-ninth-consecutive-year/) - LINCOLN, Neb.; June 5, 2024 (Business Wire) – Celerion, a leading clinical research organization, is pleased to announce it has received a CRO Leadership Award for the ninth time by global biopharmaceutical executives in Life Science Leader’s annual CRO Leadership Awards for 2024. Celerion was distinguished among 42 of their peers in the annual Contract - [Key Clinical Pharmacology Studies to Support Biologic Drug Regulatory Submission](https://www.celerion.com/blog/key-clinical-pharmacology-studies-to-support-biologic-drug-regulatory-submission/) - By Sabina Paglialunga, PhD & Aernout van Haarst, PhD; Senior Directors Scientific Affairs, Celerion Biologic drugs are pharmaceutical products derived from living organisms or their components. They represent a wide range of therapeutic treatments that include monoclonal antibodies, proteins, peptides as well as cell and gene therapies. Oligonucleotide therapeutics, on the other hand, may in - [Jo Goodman Joins Celerion as Vice President of Bioanalytical Services](https://www.celerion.com/blog/jo-goodman-joins-celerion-as-vice-president-of-bioanalytical-services/) - LINCOLN, Neb.; May 7, 2024 (Business Wire) – Celerion, a leading clinical research organization, specializing in early clinical research and bioanalytical services, today announced the appointment of Jo Goodman as Vice President of Bioanalytical Services in its Lincoln, Nebraska, laboratory. In her new role, Goodman will oversee the strategic direction and operational performance of the Lincoln bioanalytical - [12 Questions to Help Guide Renal Impairment PK Study Design](https://www.celerion.com/blog/12-questions-to-help-guide-renal-impairment-pk-study-design/) - By Sabina Paglialunga, PhD Director Scientific Affairs, Celerion Need to run a renal impairment pharmacokinetic (PK) study, but don’t know where to begin? We have you covered! Celerion has managed more than 30 renal impairment PK studies over the past decade. We have a network of clinical sites and access to patients. To begin, we’ll - [Celerion Achieves Milestone With CLIA Certification for Its Bioanalytical Laboratory, Expanding Capabilities in Clinical Trials and Diagnostic Testing](https://www.celerion.com/blog/celerion-achieves-milestone-with-clia-certification-for-its-bioanalytical-laboratory/) - LINCOLN, Neb.; Feb. 6, 2024 (Business Wire) – Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) certification for its state-of-the-art bioanalytical laboratory located in Lincoln, Nebraska. This significant milestone marks a pivotal step in Celerion’s commitment to advancing healthcare by integrating high complexity testing - [Celerion Receives a 2023 CRO Leadership Award in All Categories for the Eighth Year Running](https://www.celerion.com/blog/celerion-receives-a-2023-cro-leadership-award-in-all-categories-for-the-eighth-year-running/) - LINCOLN, Neb.; May 10, 2023 (Business Wire) – Celerion, a leading clinical research organization, has been recognized for the eighth consecutive year as the winner of a CRO Leadership Award by global biopharmaceutical executives in Clinical Leader and Life Science Leader’s annual CRO Leadership Awards for 2023. Celerion was distinguished among 46 of their peers - [Celerion Expands Its Service Offering to Include GLP/GCP Compliant Molecular and Cell Biology Testing](https://www.celerion.com/blog/celerion-expands-its-service-offering-to-include-glp-gcp-compliant-molecular-and-cell-biology-testing/) - LINCOLN, Neb.; Nov. 10, 2022 (Business Wire) – Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, announces the expansion of molecular and cellular capabilities to Good Laboratory Practice/Good Clinical Practice (GLP/GCP) standards to support the development of new modality therapies, such as cell and gene therapies. The expanded service offering is available in both of - [Adaptive Trial Designs](https://www.celerion.com/blog/adaptive-trial-designs/) - Flexibility of Adaptive Early Phase Study Designs Sabina Paglialunga, PhD Director, Scientific Affairs Adaptive clinical trials are characterized by innovative and flexible designs that incorporate safety and other information acquired during a study to instruct the next steps in a trial. Typically, these pre-planned adjustments include sample size refinement, subsequent dose level selection, or - [CRO Leadership Award Goes to Celerion for a 7th Consecutive Year](https://www.celerion.com/blog/cro-leadership-award-goes-to-celerion-for-a-7th-consecutive-year/) - Annual survey of biopharmaceutical clients recognizes Celerion for delivering customer service excellence. Lincoln, Neb. (June 15, 2022) — For the seventh consecutive year Celerion has been named recipient of the Life Science Leader and Clinical Leader’s CRO Leadership Awards in all five award categories. Well respected within the pharmaceutical industry, the awards recognize the winning - [Celerion Announces Investment in ADME Suite of Services](https://www.celerion.com/blog/celerion-announces-investment-in-adme-suite-of-services/) - The leader in early clinical development expands ADME suite to meet ongoing demand. LINCOLN, Neb., April 6, 2022 /PRNewswire/ -- Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, has announced that it has made a significant investment in its ADME (Absorption, Distribution, Metabolism and Excretion) suite of services to meet continuously increasing demand - [Celerion Expands Early Phase Clinical Pharmacology Units](https://www.celerion.com/blog/celerion-expands-early-phase-clinical-pharmacology-units/) - The leader in early clinical development adds to its facilities and services to meet continually growing demand for Phase I Studies. LINCOLN, Neb., March 8, 2022 /PRNewswire/ -- Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, has announced completion of additions to its research capacity and services. This includes the opening of a new - [Women in Leadership Spotlight: Zori Cheshmedzhieva](https://www.celerion.com/blog/women-in-leadership-spotlight-zori-cheshmedzhieva/) - Our Celerion team values the competencies and perspectives women in leadership bring to our company and our industry. Zori Cheshmedzhieva, Vice President Global Clinical Development, shares insight on what makes a great leader. There is a balance good leaders strive for in today’s world. “Be strong, but not rude; be kind, but not weak; be - [Women in Leadership Spotlight: Michelle Combs](https://www.celerion.com/blog/women-in-leadership-spotlight-michelle-combs/) - Celerion fosters a workplace environment that welcomes diversity and strong leaders. Michelle Combs, Vice President, Data Management and Biometrics, explains great leaders are those who are driven to achieve success while exhibiting courage, integrity, hard work, a sense of gratitude, and the ability to communicate their vision in an inspiring way to their team. - [Tackling the Complexity of Complex Generic Drug Development](https://www.celerion.com/blog/tackling-the-complexity-of-complex-generic-drug-development/) - Sabina Paglialunga, PhD Director, Scientific Affairs Generic drugs account for nearly 90% of all prescription medication filled in the US. Generic drugs are substitutes of a brand-name innovator medication, having the same (bioequivalent) active ingredients, dosage form, route of administration, safety profile and performance compared to a reference list drug (RLD). The FDA approves generic - [Celerion Receives CRO Leadership Award for 6th Consecutive Year](https://www.celerion.com/blog/celerion-receives-cro-leadership-award-for-6th-consecutive-year/) - Media Contact: Michelle Maklas-Baker Associate Director, Global Marketing 1 732 306 7804 michelle.maklasbaker@celerion.com Annual survey of biopharmaceutical clients honors the organization for excellence in service. Lincoln, NE (June 1, 2021) – Celerion is pleased to announce that they are the recipient of the 2021 Life Science Leader annual CRO Leadership Awards in all five award categories. This is the sixth - [Is Age Just a Number? Clinical Drug Development in Older Adults](https://www.celerion.com/blog/is-age-just-a-number-clinical-drug-development-in-older-adults/) - Sabina Paglialunga, PhD Director, Scientific Affairs What Makes Older Adults So Special? Older adults, defined as 65 years of age and up, currently represent ~17% of the general US population and is expected to rise to one-fifth of the population by 2030. Considered a ‘special population’ in the drug development, older adults may hold a - [Human Trials For Lyme Disease Shot Kickoff In Nebraska](https://www.celerion.com/blog/human-trials-for-lyme-disease-shot-kickoff-in-nebraska-netnebraska-org/) - About 500,000 Americans are diagnosed with Lyme disease each year. MassBiologics is developing a shot that fights against the most common insect-borne disease in the country. MassBiologics reached out to Celerion to test their Lyme pre-exposure prophylaxis or PrEp shot last year. - [A Decade of Innovative Technology to Accelerate Drug Development](https://www.celerion.com/blog/a-decade-of-innovative-technology-to-accelerate-drug-development/) - Celerion continues its Celebration of Translating Science into Medicine for over a decade by highlighting how Celerion ScienceSM has contributed to the development of new therapeutics using our core competencies. While Celerion’s inventive spirit began over 50 years ago, our most important contribution to human health is happening right now, against COVID-19. 2020 has been - [Leveraging Innovative Technologies to Access Better Data More Efficiently and Cost-Effectively](https://www.celerion.com/blog/leveraging-innovative-technologies-to-access-better-data-more-efficiently-and-cost-effectively/) - [The Platforms and Promise of COVID-19 Vaccines](https://www.celerion.com/blog/the-platforms-and-promise-of-covid-19-vaccines/) - by Sabina Paglialunga, PhD - Director, Scientific Affairs, Celerion COVID-19 is a highly infectious respiratory disease caused by the SARS-CoV-2 virus that has affected every corner of the world and nearly all aspects of daily life. In a subset of COVID-19 patients, an exaggerated immune response can lead to acute respiratory distress syndrome (ARDS) requiring mechanical ventilation - [Celebrating a Decade of Biosimilars Development](https://www.celerion.com/blog/celebrating-a-decade-of-biosimilars-development/) - Biosimilars are not an exact copy but are similar to the originally approved biological product. Following an abbreviated pathway, they demonstrate equivalent PK, toxicity, similarity, and no clinical change compared to the innovator. The goal of a biosimilar is to introduce lower cost alternatives that can help improve patient access to biological treatments. Celerion is - [Celerion Recognized as 2020 CRO Leadership Champion for Reliability and Receives CRO Leadership Award for Capabilities, Compatibility, Expertise, and Quality](https://www.celerion.com/blog/celerion-recognized-as-2020-cro-leadership-champion-for-reliability-and-receives-cro-leadership-award-for-capabilities-compatibility-expertise-and-quality/) - CONTACT: Lorraine M. Rusch, MSc., Ph.D. Celerion 914-548-1690 Lorraine.Rusch@Celerion.com Lincoln, Neb.; June 16, 2020 (Business Wire) – Celerion is proud to announce, for the fifth consecutive year, recognition of its early stage research development services across five categories in the 2020 CRO Leadership Awards sponsored by Life Science Leader and Industry Standard Research. Both small - [Open for Business: Early Phase Clinical Drug Development during the COVID-19 Pandemic](https://www.celerion.com/blog/open-for-business-early-phase-clinical-drug-development-during-the-covid-19-pandemic/) - The global COVID-19 pandemic has altered the mechanics of nearly every industry. For early phase clinical trials, adapting to this crisis has led to augmented risk mitigation procedures and greater use of innovative technology. Since continuity of your drug program is important to you, the patients in need of these therapies, it is important to - [Celerion Expands HRMS Metabolite Identification Capabilities for Full Service Metabolism Offering](https://www.celerion.com/blog/celerion-expands-hrms-metabolite-identification-capabilities-for-full-service-metabolism-offering/) - [COVID-19, Kawasaki and the Cytokine Storm](https://www.celerion.com/blog/covid-19-kawasaki-and-the-cytokine-storm/) - by Sabina Paglialunga, PhD - Director, Scientific Affairs, Celerion SARS-CoV-2 symptoms include fever, cough and shortness of breath. The disease is especially hard on vulnerable populations such as the elderly and those with underlying health conditions like obesity and hypertension. Now, developing reports indicate that children may also be at great risk than originally thought. - [Capturing the Cytokine Storm: Using Biomarkers in COVID-19 Trials](https://www.celerion.com/blog/capturing-the-cytokine-storm-using-biomarkers-in-covid-19-trials/) - By Sumit Kar, Lead Scientist – Biomarkers, Celerion Cytokine biomarkers are released in the body after SARS-CoV-2 viral particles are presented by antigen presenting cells initiating a cytokine storm.1 Cytokine storm, known clinically as haemophagocytic lymphohistiocytosis or cytokine release syndrome, is mostly seen after viral infections, and leads to constant fever, increased ferritin, and multi-organ - [Pharmabiotics – Spreading Culture to Therapeutic Drugs](https://www.celerion.com/blog/pharmabiotics-spreading-culture-to-therapeutic-drugs/) - In the therapeutic toolbox, there is a multitude of drug categories. For decades, small molecules have been the cornerstone of pharmacology. In recent years, biological products have ushered in a wave of therapies, and forged the path for other cell- and genetic- based treatments. Greater understanding of the microbiome in association with dysbiosis and associated - [COVID-19 Vaccines in Development](https://www.celerion.com/blog/covid-19-vaccines-in-development/) - COVID-19 Vaccines in Development COVID-19 is a respiratory illness caused by a novel coronavirus. According to the CDC, symptoms may include fever, coughing and shortness of breath. The virus is highly contagious and can spread between people who are in close contact with one another (within 6 feet) or when an infected person coughs or - [Celerion Celebrates a Decade of Translating Science Into Medicine](https://www.celerion.com/blog/celerion-celebrates-a-decade-of-translating-science-into-medicine/) - [Celerion Expands Clinical Research to Nebraska Innovation Campus](https://www.celerion.com/blog/celerion-expands-clinical-research-to-nebraska-innovation-campus/) - [Newsletter: Q3/Q4 2019](https://www.celerion.com/blog/newsletter-q3-q4-2019/) - [NASH Pathway to Approval – Light at the End of the Tunnel](https://www.celerion.com/blog/nash-pathway-to-approval-light-at-the-end-of-the-tunnel/) - Not long ago, there was very little regulatory guidance or recommendations regarding a pathway for nonalcoholic steatohepatitis (NASH) drug approval. NASH is a chronic hepatic disease that can lead to cirrhosis, liver failure and need for transplant, and currently there is no FDA-approved treatment for NASH, creating a large unmet need for patients. On the - [Celerion Celebrates 50th Anniversary of First Clinical Trial](https://www.celerion.com/blog/celerion-celebrates-50th-anniversary-of-first-clinical-trial/) - Celerion is proud to celebrate the 50th anniversary of the first clinical trial, conducted at our facilities in Lincoln, Nebraska. The company, originally called Harris Laboratories, conducted its first clinical research study in 1969, becoming one of the first organizations to offer an independent clinical research testing environment. - [Newsletter: Q2 2019](https://www.celerion.com/blog/newsletter-q2-2019/) - [Backing the Biosimilar Boon](https://www.celerion.com/blog/biosimilars/) - Biological therapies such as peptides, enzymes and antibodies have changed the face of medicine, providing crucial treatment for a number of devastating inflammatory, endocrine and oncological diseases. However, these drugs often come with a hefty price tag due to the complicated nature of manufacturing biological products which are derived from living systems. In an effort - [Celerion Recognized as a Leading Contract Research Organization for the 4th Consecutive Year](https://www.celerion.com/blog/celerion-recognized-as-a-leading-contract-research-organization-for-the-4th-consecutive-year/) - [Newsletter: Q1 2019](https://www.celerion.com/blog/newsletter-q1-2019/) - [Newsletter: Q2 2018](https://www.celerion.com/blog/newsletter-q2-2018-2/) - [Innovations in COPD - A Breath of Fresh Air](https://www.celerion.com/blog/innovations-in-copd-a-breath-of-fresh-air/) - Chronic obstructive pulmonary disease (COPD) describes a cluster of diseases linked to breathing problems and airflow blockage, such as emphysema and chronic bronchitis. COPD is often associated with cigarette smoking, and prolonged exposure to poor air quality or toxic gaseous pollutants. This chronic disease affects over 3 million people in the US each year, and - [Entering the NASH Race: Tips for Early Clinical Development](https://www.celerion.com/blog/entering-the-nash-race-tips-for-early-clinical-development/) - Nonalcoholic steatohepatitis (NASH) is a chronic liver disease that affects over 17 million Americans and this number is growing. NASH can lead to cirrhosis, end-stage liver disease, liver transplant and even hepatocellular carcinoma. Therefore, the need for treatment for this devastating, progressive disease is dire. That said, the NASH drug development landscape is robust. With - [Newsletter: Q3/Q4 2018](https://www.celerion.com/blog/newsletter-q3-q4-2018/) - [The Next Frontier of Pharmacology: Micro Drug Delivery](https://www.celerion.com/blog/next-frontier-pharmacology-micro-drug-delivery/) - Injectable medication can be burdensome for the patient, causing pain and discomfort, and can contribute to compliance issues especially when chronic treatment is required. A promising and emerging area in pharmacology that may alleviate these obstacles is transdermal microneedle drug delivery. Patch microneedles are about the size of a postage stamp and can contain ~30-50 - [Know Your Numbers Campaign](https://www.celerion.com/blog/know-numbers-campaign/) - Know Your Numbers Campaign At Celerion, our community outreach does not only serve to inform the public about who we are and medical research opportunities, but we also use this time to give back to our community. In April 2016, Celerion launched a “Know Your Numbers” campaign in the Phoenix, AZ area. Through this initiative, - [Biopharmaceutical Industry Recognizes Celerion as a Leading Contract Research Organization](https://www.celerion.com/blog/biopharmaceutical-industry-recognizes-celerion-leading-contract-research-organization/) - (Lincoln, NE April 3, 2018) – For the third consecutive year, biopharmaceutical industry executives have selected Celerion as an industry leader in multiple categories of Life Science Leader’s annual CRO Leadership Awards for 2018. Celerion was recognized as a CRO Leader in the Capabilities, Compatibility, Expertise, Quality and Reliability categories across all three groups of respondents (big pharma, small pharma, - [Newsletter: Q2 2018](https://www.celerion.com/blog/newsletter-q2-2018/) - [Industry Leading Nicotine Researcher Joins Celerion Research Team](https://www.celerion.com/blog/industry-leading-nicotine-researcher-joins-celerion-research-team/) - Industry Leading Nicotine Researcher Joins Celerion Research Team Dr. Ian Fearon further enhances Celerion’s renowned capabilities Lincoln, NE (January 23, 2018) - Celerion, the leader in Nicotine Clinical Research Services, is pleased to announce that Dr. Ian M. Fearon has joined Celerion’s industry leading Nicotine Research Team. Prior to joining Celerion, Dr. Fearon was Principal - [Celerion Creates a Fully Automated, Early Development Clinical Trial Data Management Platform](https://www.celerion.com/blog/celerion-creates-fully-automated-early-development-clinical-trial-data-management-platform/) - Celerion Creates a Fully Automated, Early Development Clinical Trial Data Management Platform Lincoln, NE (January 17, 2018) - Celerion, the leader in early clinical development, is pleased to announce a new core capability for this growing market: the integration of ClinQuick®, Celerion’s proprietary electronic data acquisition system, with TrialMaster®, OmniComm’s electronic data capture solution, to - [Newsletter: Q1 2018](https://www.celerion.com/blog/newsletter-q1-2018/) - [Prediabetes, the New Normal in Early Clinical Research](https://www.celerion.com/blog/prediabetes-the-new-normal-in-early-clinical-research/) - Prediabetes, the New Normal in Early Clinical Research There is a growing shift in inclusion criteria from healthy normal subjects to patient groups in early drug development. For programs with a chronic metabolic disease investigational product, prediabetes subject enrollment in early phase studies can facilitate the detection of efficacy signals and proof-of-concept [1]. Prediabetes describes - [Newsletter: Q4 2017](https://www.celerion.com/blog/newsletter-q4-2017/) - [Newsletter: Q3 2017](https://www.celerion.com/blog/newsletter-q3-2017/) - [Celerion Receives a 2017 CRO Leadership Award in Multiple Categories for Clinical Research Excellence](https://www.celerion.com/blog/celerion-receives-a-2017-cro-leadership-award-in-multiple-categories-for-clinical-research-excellence/) - Celerion Receives a 2017 CRO Leadership Award in Multiple Categories for Clinical Research Excellence Lincoln, NE (June 20, 2017) — Celerion, a leading clinical research organization, is pleased to announce it has received a CRO Leadership Award for the fourth time by global biopharmaceutical executives in Life Science Leader’s annual CRO Leadership Awards for 2017. - [Newsletter: Q2 2017](https://www.celerion.com/blog/newsletter-q2-2017/) - [Celerion Implements Biometric Fingerprint Technology and Marks Five-Year Anniversary with Verified Clinical Trials](https://www.celerion.com/blog/celerion-implements-biometric-fingerprint-technology-and-marks-five-year-anniversary-with-verified-clinical-trials/) - Celerion Implements Biometric Fingerprint Technology and Marks Five-Year Anniversary with Verified Clinical Trials Lincoln, NE; March 14, 2017 – Celerion, the premier provider of innovative early clinical research solutions, is pleased to announce that it has implemented Verified Clinical Trials (VCT) biometric fingerprint technology to prevent dual enrollment in clinical trials. Celerion was the first - [Celerion Appoints Dr. Marc Hoffman as Chief Medical Officer](https://www.celerion.com/blog/celerion-appoints-dr-marc-hoffman-as-chief-medical-officer/) - Celerion Appoints Dr. Marc Hoffman as Chief Medical Officer Lincoln, NE (February 22, 2017) - Celerion, continues to grow in response to the evolving needs of early clinical research. With the increasing focus on evaluating drug effects in relevant patient populations earlier in development, Celerion is pleased to announce that Dr. Marc Hoffman has joined - [Newsletter: Q1 2017](https://www.celerion.com/blog/newsletter-q1-2017/) - [Celerion Announces Celexus as a Premier Safety Reporting Tool for Phase I Clinical Trials](https://www.celerion.com/blog/celerion-announces-celexus-as-a-premier-safety-reporting-tool-for-phase-i-clinical-trials/) - Celerion Announces Celexus as a Premier Safety Reporting Tool for Phase I Clinical Trials Lincoln, NE (November 17, 2016) - Celerion is pleased to announce a key technology addition to its early clinical development capabilities, Celexus®. Celexus® offers clients a first look at their early clinical research data in real-time, as it is collected in - [Celerion Named Best Translational Clinical Pharmacology Company 2016](https://www.celerion.com/blog/celerion-named-best-translational-clinical-pharmacology-company-2016/) - Celerion Named Best Translational Clinical Pharmacology Company 2016 Lincoln, NE (October 5, 2016) — Celerion is pleased to announce that it is the recipient of the 2016 International Life Sciences Award in the Best Translational Clinical Pharmacology Company category. The awards panels evaluated global nominees over a wide range of parameters including leadership in innovation, - [Newsletter: Q4 2016](https://www.celerion.com/blog/newsletter-q4-2016/) - [Supporting the Next Major Health Epidemic](https://www.celerion.com/blog/supporting-the-next-major-health-epidemic/) - Supporting the Next Major Health Epidemic Non-alcoholic fatty liver disease (NAFLD)/Non-alcoholic steatohepatitis (NASH) is viewed as the next major health epidemic and with no current anti-NASH medication on the market to treat this chronic disease; it is expected to place a heavy burden on our healthcare systems. NAFLD is considered to be a hepatic manifestation - [Celerion Recognized by Biopharmaceutical Clients as a Leader in Contract Research Quality Benchmarking Survey](https://www.celerion.com/blog/celerion-recognized-by-biopharmaceutical-clients-as-a-leader-in-contract-research-quality-benchmarking-survey/) - Celerion Recognized by Biopharmaceutical Clients as a Leader in Contract Research Quality Benchmarking Survey (Lincoln, NE May 26, 2016) –Celerion has been highlighted as an industry leader by highly experienced global biopharmaceutical executives in Life Science Leader’s annual CRO Leadership Awards for 2016. Celerion was recognized across multiple categories amongst 65 of their peers including - [Assign Clinical Research Joins Celerion](https://www.celerion.com/blog/assign-clinical-research-joins-celerion/) - Assign Clinical Research Joins Celerion (Lincoln, NE Jan 11, 2016) – Celerion is pleased to announce that effective January 1 2016, Assign Clinical Research, headquartered in Vienna, Austria, has joined Celerion, further expanding our global presence and capabilities in the conduct of complex early clinical studies. Assign conducts early stage clinical studies, as well as - [Celerion Expands its Cell-Based Assays Capabilities in Global Bioanalytical Services](https://www.celerion.com/blog/celerion-expands-its-cell-based-assays-capabilities-in-global-bioanalytical-services/) - Celerion Expands its Cell-Based Assays Capabilities in Global Bioanalytical Services (Lincoln, NE; Nov 3, 2014) – Celerion announces the expansion of laboratory capabilities to meet growing demand for cell-based assays. Assays involving whole cells provide a variety of measures of drug activity or effect that can be important endpoints in clinical research. Celerion has expanded this capability - [Celerion Completes Recapitalization Through Investment by MTS Capital Health Partners](https://www.celerion.com/blog/celerion-completes-recapitalization-through-investment-by-mts-capital-health-partners/) - Celerion Completes Recapitalization Through Investment by MTS Capital Health Partners (Lincoln, NE; Oct 29, 2014) – Celerion announces the successful recapitalization of its business through investment by MTS Health Investors, LLC, the New York-based healthcare private equity firm. MTS has partnered with management and will provide capital to support future growth. With operations throughout North America, Europe - [Celerion Announces Membership into the Cardiac Safety Research Consortium (CSRC)](https://www.celerion.com/blog/celerion-announces-membership-into-the-cardiac-safety-research-consortium-csrc/) - Celerion Announces Membership into the Cardiac Safety Research Consortium (CSRC) (Lincoln, NE; Oct 15, 2014) – Celerion is pleased to announce our membership into the Cardiac Safety Research Consortium (CSRC). As a member of the CSRC, Celerion will engage with other thought leaders on key issues that impact cardiovascular safety. This will include discussions regarding alternative approaches - [Celerion Expands Ophthalmological Capabilities to Patient Populations in Collaboration with Queen’s University, Belfast](https://www.celerion.com/blog/celerion-expands-ophthalmological-capabilities-to-patient-populations-in-collaboration-with-queens-university-belfast-2/) - (Lincoln, NE; Sep 30, 2014) – Celerion announces the expansion of ophthalmological services in our Belfast, Northern Ireland UK facility, by building on our successful relationship with Queen’s University in Belfast. Celerion will expand our collaboration with Queen’s University for access to patient populations, specialized procedures and their scientific expertise in this area. This new focus will - [Celerion Appoints Dr. Robert Lester as Chief Cardiologist, Global Medical Director of Cardiac Safety Services](https://www.celerion.com/blog/celerion-appoints-dr-robert-lester-as-chief-cardiologist-global-medical-director-of-cardiac-safety-services/) - Celerion Appoints Dr. Robert Lester as Chief Cardiologist, Global Medical Director of Cardiac Safety Services (Lincoln, NE; Jun 16, 2014) – Celerion is pleased to announce the appointment of Robert Lester MD FACC, as Chief Cardiologist, Global Medical Director of Cardiac Safety Services. Dr. Lester will develop and lead Celerion’s strategic vision in Cardiac Safety - [Celerion Selected by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium for The Beta Cell Project](https://www.celerion.com/blog/celerion-selected-by-the-foundation-for-the-national-institutes-of-health-fnih-biomarkers-consortium-for-the-beta-cell-project/) - Celerion Selected by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium for The Beta Cell Project (Lincoln, NE; Jun 11, 2014) – Celerion is pleased to announce it has been selected by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium to provide clinical support for The Beta Cell Project. - [Celerion and Korean Drug Development Fund Form Collaboration to Strengthen Early Phase Clinical Research in South Korea](https://www.celerion.com/blog/celerion-and-korean-drug-development-fund-form-collaboration-to-strengthen-early-phase-clinical-research-in-south-korea/) - Celerion and Korean Drug Development Fund Form Collaboration to Strengthen Early Phase Clinical Research in South Korea (Lincoln, NE; Seoul, ROK, May 28, 2014) – Celerion and the Korean Drug Development Fund (KDDF) are pleased to announce their formal collaboration to provide drug development expertise and support for the emerging drug discovery and development industry in South Korea. The - [Celerion Opens Operations in South Korea at Seoul National University Hospital Clinical Trial Center](https://www.celerion.com/blog/celerion-opens-operations-in-south-korea/) - Celerion Opens Operations in South Korea at Seoul National University Hospital Clinical Trial Center (Lincoln, NE; Mar 4, 2014) – Celerion is pleased to announce the expansion of clinical operations to South Korea. Through partnership with Seoul National University Hospital (SNUH), the new Asian office is located within the SNUH Clinical Trials Center. This enables Celerion - [Celerion Celebrates 80 Years of Conducting Business at Global Headquarters in Lincoln, Nebraska](https://www.celerion.com/blog/celerion-celebrates-80-years-of-business-at-global-headquarters-in-lincoln-nebraska/) - Celerion Celebrates 80 Years of Conducting Business at Global Headquarters in Lincoln, Nebraska (Lincoln, NE; Dec 17, 2013) – Celerion is proud to announce the 80th anniversary of operations at our first facility in Lincoln, Nebraska. Celerion is at the forefront of early clinical research with corporate headquarters in Lincoln, plus seven other facilities globally involving 950 employees - [Celerion Appoints John Horkulak as Executive Director, Eurasian Site Operations](https://www.celerion.com/blog/john-horkulak/) - Celerion Appoints John Horkulak as Executive Director, Eurasian Site Operations (Lincoln, NE; Dec 5, 2013) – Celerion is pleased to announce the appointment of John Horkulak as Executive Director, Eurasian Site Operations. Mr. Horkulak will lead the efforts to further expand the company’s early phase patient capabilities in Europe and Asia. The appointment of Mr. Horkulak continues to - [Celerion Appoints Clayton Dehn as Executive Director, Metabolic Diseases](https://www.celerion.com/blog/clayton-dehn/) - Celerion Appoints Clayton Dehn as Executive Director, Metabolic Diseases (Lincoln, NE; Nov 5, 2013) – Celerion is pleased to announce the appointment of Clayton Dehn as Executive Director, Metabolic Diseases. Mr. Dehn will lead the expansion of Celerion’s current capabilities that support early Proof-of-Concept in the development of diabetes, obesity, metabolic and cardio-metabolic interventions. The appointment of Mr. - [Celerion Expands Belfast Facility with Containment Room to Enable Live Biologics and Vaccine Studies](https://www.celerion.com/blog/celerion-expands-belfast-facility-with-containment-room-to-enable-live-biologics-and-vaccine-studies/) - Celerion Expands Belfast Facility with Containment Room to Enable Live Biologics and Vaccine Studies. (Lincoln, NE; June 5, 2013) – Celerion announces the addition of a Containment Room at the Belfast, Northern Ireland UK facility. The new Containment Room will allow Celerion to develop programs that require studies utilizing biologics, as well as vaccines with primary - [Celerion appoints Dr. Bruce Morimoto as Executive Director, Applied Translational Medicine](https://www.celerion.com/blog/celerion-appoints-dr-bruce-morimoto-as-executive-director-applied-translational-medicine/) - Celerion appoints Dr. Bruce Morimoto as Executive Director, Applied Translational Medicine (Lincoln, NE; May 21, 2013) – Celerion is pleased to announce the appointment of Dr. Bruce Morimoto as Executive Director of Applied Translational Medicine. Dr. Morimoto will have responsibility for developing and implementing strategies for patient populations in early clinical research and clinical pharmacology - [Types and Features of NDA Enabling](https://www.celerion.com/blog/types-and-features-of-nda-enabling/) - Types and Features of NDA Enabling Studies J. Fred Pritchard, Ph.D. Vice President, Global Drug Development NDA-enabling studies such as drug-drug interactions, food effect and ADME are required to support a marketing application. Celerion is able to proactively create efficient and cost-effective packages of NDA-enabling studies, thereby allowing the same team of scientists to apply - [Celerion Builds on Respiratory Capabilities With the Addition of an On-site Bronchoscopy Suite](https://www.celerion.com/blog/bronchoscopy-suite/) - Celerion Builds on Respiratory Capabilities With the Addition of an On-site Bronchoscopy Suite (Lincoln, NE; Jan 9, 2013) – Celerion, the premier provider of innovative early stage drug development solutions, announces the expansion of its capabilities in the respiratory therapeutic area, with the addition of a dedicated Bronchoscopy Suite in the Belfast, Northern Ireland, UK facility. The - [Celerion is the First CRO Headquartered in the USA to Receive Full Accreditation from AAHRPP](https://www.celerion.com/blog/aahrpp-accreditation/) - Celerion is the First CRO headquartered in the USA to Receive Full Accreditation from AAHRPP. (Lincoln, NE; Sep 17, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that it has been awarded full accreditation by the Association for the Accreditation Human Research Protection Programs (AAHRPP). Celerion’s clinical facilities - [Celerion announces expanded state-of-the-art ADME Suite in its Lincoln, Nebraska USA facility](https://www.celerion.com/blog/adme-suite/) - Celerion announces expanded state-of-the-art ADME Suite in its Lincoln, Nebraska USA Facility The state-of-the-art ADME Suite benefits from on-site bioanalytical services and Phase I clinical facilities to offer clients a one stop solution. (Lincoln, NE; May 17, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that it has - [Celerion and Ricerca Biosciences announces “The Biosimilars Alliance” to offer clients a more effective development path for biosimilars](https://www.celerion.com/blog/the-biosimilars-alliance/) - Celerion and Ricerca Biosciences announces “The Biosimilars Alliance” to offer clients a more effective development path for biosimilars (Lincoln, NE; Feb 29, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, and Ricerca Biosciences, a drug safety assessment expert in harnessing external preclinical innovation, announce the formation of “The Biosimilars Alliance”. - [Celerion First Early Stage Contract Research Organization to Adopt a Participant Verification System to Improve Participant Safety and Data Quality](https://www.celerion.com/blog/celerion-first-early-stage-contract-research-organization-to-adopt-a-participant-verification-system-to-improve-participant-safety-and-data-quality/) - Celerion First Early Stage Contract Research Organization to Adopt a Participant Verification System to Improve Participant Safety and Data Quality (Lincoln, NE; Feb 02, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce it has implemented VCT Verify™ from Verified Clinical Trials, to instantaneously ensure accurate participant - [Celerion scientist proud recipient of Scientific and Technological Achievement Award (STAA) from EPA](https://www.celerion.com/blog/celerion-employee-proud-recipient-of-scientific-and-technological-achievement-award-staa-from-epa-2/) - Celerion scientist proud recipient of Scientific and Technological Achievement Award (STAA) from EPA. (Lincoln, NE; Jan 11, 2012) - Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce Don Graff, PharmD, has received the prestigious Scientific and Technological Achievement Award (STAA) from the United States Environmental Protection Agency (EPA). - [Celerion receives license enabling Investigational Medicinal Products (IMPs) to be imported directly to their GMP-licensed facility](https://www.celerion.com/blog/celerion-receives-license-enabling-investigational-medicinal-products-imps-to-be-imported-directly-to-their-gmp-licensed-facility/) - Celerion receives license enabling Investigational Medicinal Products (IMPs) to be imported directly to their GMP-licensed facility The addition of the Import license saves time, costs and initiates direct communication earlier with clients to expedite early stage clinical studies. (Lincoln, NE; Sep 07, 2011) - Celerion, the premier provider of innovative early stage drug development solutions, - [Celerion appoints Dr. Raymond Farmen as Vice President of Global Bioanalytical Services](https://www.celerion.com/blog/celerion-appoints-dr-raymond-farmen-as-vice-president-of-global-bioanalytical-services/) - Celerion appoints Dr. Raymond Farmen as Vice President of Global Bioanalytical Services (Lincoln, NE; Jun 29, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce the appointment of Dr. Raymond Farmen as Vice President of Global Bioanalytical Services. Dr. Farmen will have responsibility for the company’s bioanalytical - [Celerion achieves major milestone of successfully analyzing over 25,000 platelet aggregation samples](https://www.celerion.com/blog/celerion-achieves-major-milestone-of-successfully-analyzing-over-25000-platelet-aggregation-samples/) - Celerion achieves major milestone of successfully analyzing over 25,000 platelet aggregation samples. Celerion’s unmatched experience in platelet aggregation benefits clients by producing higher quality data, reduced timelines and lower costs. (Lincoln, NE; Jun 21, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces it has achieved a major milestone of - [Celerion announces highly automated ECG analysis enabling data delivery within 37 days from first patient dosed](https://www.celerion.com/blog/celerion-announces-highly-automated-ecg-analysis-enabling-data-delivery-within-37-days-from-first-patient-dosed/) - Celerion announces highly automated ECG Analysis enabling data delivery within 37 days from first patient dosed Clients benefit from faster access to higher quality data and cost savings in their drug development programs. (Lincoln, NE; Jun 20, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces the successful completion of - [Celerion receives ANVISA certification](https://www.celerion.com/blog/celerion-receives-anvisa-certification/) - Celerion receives ANVISA certification Brazilian Regulatory Agency Approves Celerion Facilities in both North America and Europe to Conduct Clinical Research and Bioanalytical Services. (Lincoln, NE; Jun 9, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that its clinical research operations in Belfast, Northern Ireland UK, and - [Celerion awarded prestigious LEED® Green Building Certification](https://www.celerion.com/blog/celerion-awarded-leed-silver/) - Celerion Awarded Prestigious LEED® Green Building Certification Celerion is the first research clinic in the U.S. to be awarded LEED® Silver certification. (Lincoln, NE; May 26, 2011) – Celerion, a premier provider of innovative early stage drug development solutions, announced today that it has been awarded LEED® Silver established by the U.S. Green Building Council - [Member of UK Respiratory Therapeutic Capability Cluster](https://www.celerion.com/blog/member-of-uk-respiratory-therapeutic-capability-cluster/) - The membership of Celerion’s Belfast facility within the UK Respiratory Therapeutic Capability Cluster enables faster access to patient populations, specialists and techniques in Phase I & IIa studies. Clients benefit from faster access to data that expedites decision making and speeds up the path to clinical Proof-of-Concept. (Lincoln, NE; Mar 28, 2011) – Celerion, the premier - [Celerion recognized as member of the UK Respiratory Therapeutic Capability Cluster](https://www.celerion.com/blog/celerion-recognized-as-member-of-the-uk-respiratory-therapeutic-capability-cluster/) - Celerion recognized as member of the UK Respiratory Therapeutic Capability Cluster The membership of Celerion’s Belfast facility within the UK Respiratory Therapeutic Capability Cluster enables faster access to patient populations, specialists and techniques in Phase I & IIa studies. Clients benefit from faster access to data that expedites decision making and speeds up the path - [Celerion adds USP Clean Room, enabling efficient execution of microtracer and microdosing studies](https://www.celerion.com/blog/celerion-adds-usp-compliant-clean-room-enabling-efficient-execution-of-microtracer-and-microdosing-studies/) - Celerion adds USP -compliant Clean Room, enabling efficient execution of microtracer and microdosing studies The addition of the USP Clean Room to Celerion’s Phase I core capabilities, enables sterile extemporaneous compounding in-house for microtracer studies. Clients benefit by accessing quality data earlier in drug development process. (Lincoln, NE; Mar 2, 2011) – Celerion, the - [Celerion and BryanLGH Health System Form Alliance to Provide Dedicated Hospital Beds for Phase I Studies](https://www.celerion.com/blog/celerion-and-bryanlgh-health-system-form-alliance-to-provide-dedicated-hospital-beds-for-phase-i-studies/) - Celerion and BryanLGH Health System Form Alliance to Provide Dedicated Hospital Beds for Phase I Studies (Lincoln, NE; Dec 9, 2010) –Celerion, the premier provider of innovative early stage clinical research solutions, and BryanLGH Health System, a locally owned, non-profit healthcare organization, announce an alliance to provide a dedicated wing at BryanLGH Medical Center West - [Celerion launches electronic laboratory notebook, achieving major milestone toward 100% paperless laboratories](https://www.celerion.com/blog/celerion-launches-electronic-laboratory-notebook-achieving-major-milestone-toward-goal-of-100-paperless-laboratories/) - Celerion launches electronic laboratory notebook, achieving major milestone toward goal of 100% paperless laboratories. Newly implemented electronic laboratory notebook enables faster access to data and real-time data integrity from ongoing quality control throughout the bioanalytical workflow. (Lincoln, NE; Nov 12, 2010) – Celerion, the premier provider of innovative early stage drug development solutions, announces implementation - [Celerion launches new Hybrid ECG Core Lab for Phase I clinics](https://www.celerion.com/blog/celerion-launches-new-hybrid-ecg-core-lab-for-phase-i-clinics/) - Celerion launches new Hybrid ECG Core Lab for Phase I clinics Hybrid ECG Core lab provides clients faster access to data, cost savings and higher quality of data (Lincoln, NE; Jun 2, 2010) – Celerion, the premier provider of innovative early stage clinical research solutions, announces the launch of a new Hybrid Phase I/ ECG - [Celerion acquires early stage clinical research operations from MDS Pharma Services](https://www.celerion.com/blog/celerion-acquires-early-stage-clinical-research-operations-from-mds-pharma-services/) - Celerion acquires early stage clinical research operations from MDS Pharma Services (Lincoln, NE, Mar 29, 2010) – Celerion, a privately owned contract research organization (CRO), has completed the acquisition of the development and regulatory services consultancy and early stage development operations of MDS Pharma Services. The acquired assets include five clinical research facilities and two - [Tue Apr 24, 2012 Webinar: Discerning Early Clinical Signals of Efficacy for Treating Respiratory Diseases](https://www.celerion.com/blog/tue-apr-24-webinar-discerning-early-clinical-signals-of-efficacy-for-treating-respiratory-diseases/) - [Tue Mar 20, 2012 Webinar: Challenges in Early Comparability Assessment of Biosimilars](https://www.celerion.com/blog/webinar-challenges-in-early-comparability-assessment-of-biosimilars/) ## Pages - [Home](https://www.celerion.com/) - Celerion is committed to implementing innovative strategies with applied translational medicine to gain insights on early drug development decisions. We provide vital expertise and experience in a large clinical capacity to ensure our clients are getting their product to the market faster. - [Careers](https://www.celerion.com/careers/) - At Celerion we are always interested in working with the best and brightest. Check out our current career opportunities and join our team! - [About](https://www.celerion.com/about/) - Every day, we use our experience, agility, and innovative research strategies to help get your drug to market faster—so your treatments can touch the lives of family, friends, and people in need around the world. Discover what makes Celerion more than your average Clinical Research Organization (CRO). - [Clinical Data Science Services](https://www.celerion.com/services/data-management-and-biometric-services/clinical-data-science-services/) - Celerion's clinical data management technology helps conduct trials faster. Learn how electronic data capture (EDC) can streamline the way you manage data! - [Lincoln, Nebraska](https://www.celerion.com/clinicaltrialfacilites/lincoln/) - Lincoln, Nebraska – Your Most Experienced Partner Delivering results since 1969 | Our original established Phase I Research Unit Well-known across the industry for its welcoming environment and compassionate staff, our original Phase I unit brings five decades of proven performance together with the industry’s most advanced specialized capabilities and an integrated, state-of-the-art bioanalytical laboratory. - [Privacy Policy](https://www.celerion.com/privacy-policy/) - At Celerion, Protecting the Privacy and Security of Personal Information of Individuals is Essential and Fundamental to our Values and to the Way We Do Business. Our website privacy policy is part of that commitment. Celerion complies with all data protection, privacy and security laws and regulations applicable to our organization, including but not limited - [Bioanalytical Science Services](https://www.celerion.com/services/bioanalytical-science-services/) - Celerion's state-of-the-art research labs in Lincoln, NE, and Zurich, Switzerland, combine cutting-edge technologies with internal clinical units in the US and EU for swift PK, immunogenicity, and biomarker assay data turnaround. - [Biosimilar Testing Services](https://www.celerion.com/services/bioanalytical-science-services/biosimilar-testing/) - Celerion leverages over 25 years of biologics experience to drive successful biosimilar programs, offering a deep understanding of originator products to evaluate bioanalytical similarity. Our services include a comprehensive suite of bioanalytical assays, immunogenicity assessments, and pharmacodynamic biomarkers. - [Metabolite Profiling Services](https://www.celerion.com/services/bioanalytical-science-services/metabolite-profiling-services/) - Offering expertise from in vitro metabolite identification to human ADME studies, our seasoned scientists work closely with clients, delivering insights, explanations, and tailored solutions for comprehensive drug development support. - [Gene Therapy Analytical Services](https://www.celerion.com/services/bioanalytical-science-services/gene-therapy-analytical-services/) - Platforms & Performance Celerion’s rapidly expanding gene therapy focus supports our clients’ bioanalytical needs for drug development by utilizing our international laboratories and top-fight scientists. The Evolving Role of Gene Therapy in Drug Development Gene therapy medicinal products (GTMPs) generally consist of a vector or delivery formulation/ system with an expressed therapeutic sequence including a - [Immunogenicity Testing Services](https://www.celerion.com/services/bioanalytical-science-services/immunogenicity-testing/) - With over 30 years of expertise, Celerion is a pioneer in immunogenicity assessment, employing diverse immunoanalytical and cell-based technologies to evaluate the safety and efficacy of biologic drugs, mitigating risks of severe reactions. - [Biomarker Analysis Services](https://www.celerion.com/services/bioanalytical-science-services/biomarker-analysis-services/) - Discover how Celerion's expertise in soluble biomarkers enhances drug safety and efficacy evaluations. With diverse technology platforms and experience in multiple matrices, we offer tailored three-tier biomarker validations in a GLP-compliant environment, meeting global regulatory standards. - [Solutions](https://www.celerion.com/services/early-phase-service/solutions/) - Explore our early phase solutions and discover the benefits of working with Celerion to develop your Phase 1 clinical trial design. You can be sure that our signature speed, expertise, and strategic insights are applied beginning at the earliest step of your drug's development. - [Pharmacokinetics/Pharmacodynamics (PK/PD) Analysis](https://www.celerion.com/services/bioanalytical-science-services/pkpd-analysis/) - PK/PD Analysis Services Celerion has extensive expertise in Pharmacokinetics/Pharmacodynamics (PK/PD) data generation. Let’s collaborate on the ideal investigative approach for your study. PK/PD ANALYSIS Chromatography PK/PD ANALYSIS Ligand-Binding Explore our Research Solutions PK/PD ANALYSIS Insightful Analysis for PK/PD IMMUNOGENICITY Multi-tier Immunogenicity Assay Expertise BIOMARKERS Make Better Decisions Faster with Biomarkers BIOSIMILARS Explore the Best Approaches - [Ligand-Binding](https://www.celerion.com/services/bioanalytical-science-services/pkpd-analysis/ligand-binding/) - Streamlining Bioanalysis of Biologics Ligand-Binding We use immunoanalytical techniques such as ELISA, RIA, AlphaLISA, Electrochemiluminescence (ECLA) and ultrasensitive SIMOA which are critical for the analysis of protein molecules and antibody drugs, including biosimilars. - [Chromatography](https://www.celerion.com/services/bioanalytical-science-services/pkpd-analysis/chromatography/) - Wide Variety of LC-MS Platforms Chromatography Celerion is one of the earliest established LC-MS/MS laboratories in the industry - [Services](https://www.celerion.com/services/) - Celerion offers comprehensive clinical research services for Phases 1-3 of drug development, enabling you to get your product to market faster and make earlier go/no-go decisions. - [Food Effect Studies](https://www.celerion.com/services/early-phase-service/food-effect-studies/) - Our specialized food effect capabilities ensure precise control of nutritional variables critical for accurate bioavailability assessments under fed and fasted conditions. Key Capabilities SPECIALIZED MEAL PREPARATION by registered dietitians in an on-site kitchen, providing specified, consistent diets for fed/fasted studies PROVEN REGULATORY EXCELLENCE with positive FDA inspection history, demonstrating consistent compliance, quality standards, and inspection - [Thorough QT (TQT) Studies](https://www.celerion.com/services/early-phase-service/thorough-qt-tqt-studies/) - Celerion’s cardiac safety expertise combines large-scale operational capacity with specialized ECG monitoring capabilities to support comprehensive QT assessment studies. Key Capabilities IN-HOUSE ECG CORE LAB with board-certified cardiologists providing expert ECG interpretation and dedicated equipment streamlined with clinical operations EXPERT ECG TECHNICIANS experienced in placement of ECG leads and Holter monitors PLACEBO AND POSITIVE CONTROL - [ECG Core Lab for Cardiac Trials](https://www.celerion.com/innovations/ecg-core-lab-for-cardiac-trials/) - Our highly automated ECG Core Lab utilizes clinical research technology to provide shorter start-up times, research flexibility, and increased data integrity. From collection to analysis, this enables faster access to high-quality data, at a lower cost for you. - [Sites](https://www.celerion.com/clinicaltrialfacilites/) - Explore Celerion's global early phase centers and discover the advantages of a dedicated recruitment team and a culture focused on quality, efficiency and the delivery of high-quality, accurate data. - [Participant Recruitment](https://www.celerion.com/about/volunteer-recruitment/) - At Celerion we provide opportunities for healthy volunteers to participate in paid clinical trials. Learn more about our volunteer recruitment process and see if you are eligible to help us develop treatments for our communities. - [Renal & Hepatic Impairment Studies](https://www.celerion.com/expertise/renal-and-hepatic-impairment-studies/) - Utilizing experience from over 40 renal insufficiency studies, we evaluate the safety of your emerging drug and help you navigate the ever-changing regulatory landscape. We offer full-service expertise with our renal insufficiency analysis to get your product to market faster. - [Tobacco Harm Reduction Studies](https://www.celerion.com/expertise/tobacco-harm-reduction-studies/) - Evaluating Modified Risk Tobacco Products For more than 25 years Celerion has performed data driven research in the tobacco/nicotine product industry for the evaluation of potentially risk reducing tobacco and nicotine-containing products. Through either direct design or consulting, Celerion has managed clinical studies ranging from small PK, or exploratory biomarker studies to multi-year programs in - [Drug-Drug Interaction (DDI)](https://www.celerion.com/services/early-phase-service/drug-drug-interaction-ddi/) - Our comprehensive DDI capabilities support complex interaction studies with the infrastructure and expertise needed for multi-compound protocols and NDA-enabling study programs. Key Capabilities LARGE CLINIC CAPACITY providing flexibility for scheduling multiple concurrent studies PROCUREMENT AND MANAGEMENT of interactive medications and complex dosing regimens BIOANALYTICAL SERVICES for analysis of interactive medications with validated methods ON-SITE CAP/CLIA-CERTIFIED - [Pharmacodynamic (PD) Studies](https://www.celerion.com/services/early-phase-service/pharmacodynamic-pd-studies/) - Celerion’s pharmacodynamic capabilities support complex biomarker and mechanism-of-action studies with specialized procedures and comprehensive safety monitoring. Key Capabilities PROTOCOL DEVELOPMENT SUPPORT with writers and scientists experienced in PD study design and biomarker protocol development SPECIALIZED SAMPLE COLLECTION including biopsies, cerebrospinal fluid (CSF), and other biological samples NETWORK OF MEDICAL SPECIALISTS including optometry, anesthesiology, neurology, and - [Radiolabeled (ADME) Studies](https://www.celerion.com/services/early-phase-service/radiolabeled-adme-studies/) - Our comprehensive radiolabeled drug capabilities include on-site nuclear pharmacy services and specialized handling expertise for complete absorption, distribution, metabolism, and excretion studies. Key Capabilities PROTOCOL DEVELOPMENT SUPPORT with writers and scientists experienced in ADME study design and radiolabeled compound protocols ON-SITE NUCLEAR PHARMACY led by nuclear pharmacist for preparation of sterile and non-sterile radiolabeled dosage - [Single Ascending Dose/Multiple Ascending Dose](https://www.celerion.com/services/early-phase-service/single-ascending-dose-multiple-ascending-dose/) - Celerion’s first-in-human and dose escalation expertise provides the safety infrastructure and rapid decision-making capabilities essential for early-phase development programs. Key Capabilities PROTOCOL DEVELOPMENT SUPPORT with writers and scientists experienced in dose escalation design and first-in-human study protocols ESTABLISHED DOSE ESCALATION PROTOCOLS with results available within 24 hours for rapid go/no-go decisions FULL-TIME INVESTIGATORS AND ACLS-CERTIFIED - [Phoenix, Arizona](https://www.celerion.com/clinicaltrialfacilites/phoenix/) - Phoenix, Arizona – Your Largest-Capacity Partner Delivering results since 1985 | Located in Tempe, minutes from Phoenix Sky Harbor International Airport When your study demands maximum scale and speed, our purpose-built facility delivers the industry’s largest Phase I capacity with uncompromising quality standards and unmatched convenience. Why Phoenix Accelerates Your Success 350+ beds including Intensive - [Belfast, UK](https://www.celerion.com/clinicaltrialfacilites/belfast/) - Belfast, UK – Your European Gateway Three and a half decades since 1990 | Located in the heart of this historical city Access Europe’s regulatory pathway through a facility that combines local expertise, prestigious university partnerships, and rapidly expanding state-of-the-art capabilities. Why Belfast Advances Your Global Strategy 78 beds across four clinical wards Customizable configurations - [The Future of Pharmacy](https://www.celerion.com/pharmacy/) - Celerion is paving the way for the future of pharmacy. With our newly upgraded compounding suites and decades of experience, we’re ready to conduct faster, better, future-focused research for you. - [Clinical Protocol Development](https://www.celerion.com/services/data-management-and-biometric-services/clinical-protocol-development/) - At Celerion our scientists use industry-leading study designs that reduce time from First-in-Human to clinical proof-of-concept. Discover how our clinical trial protocol design process helps maximize the amount of information gathered and reduce overall costs. - [PK/PD Modeling and Analysis](https://www.celerion.com/services/data-management-and-biometric-services/pkpd-modeling/) - Celerion utilizes clinical pharmacokinetics and clinical pharmacodynamics to understand how bodies interact with new drugs. Trust Celerion to deliver insights about the absorption and effectiveness of your future product. - [Regulatory Medical Writing & Reporting](https://www.celerion.com/services/data-management-and-biometric-services/regulatory-medical-writing-and-reporting/) - Celerion is committed to delivering high quality medical writing services within the established timelines facilitated by our team of expert medical writers. Let us show you how our medical reporting services shortens project timelines and improves the accuracy of data. - [Environmental, Social, and Governance (ESG) Initiatives](https://www.celerion.com/about/esg-at-celerion/) - Celerion's ESG policy embodies our commitment to positive impact, aligning with our mission to accelerate client drug market entry, benefiting global communities. Dedicated to ethical, legal, and environmentally friendly practices, we ensure privacy, security, human rights, and quality innovation. - [Global Clinical Development](https://www.celerion.com/services/global-clinical-development/) - Through the entirety of our client's drug development process, Celerion is well-positioned to adapt to the complexity of clinical trials. From Phase 2 to Phase 3 clinical trials, our team applies their knowledge and abilities to guide through clinical research, development, and data management. - [Regulatory Product Labeling Studies](https://www.celerion.com/expertise/regulatory-product-labeling-studies/) - With Celerion, you can depend on us to properly comply with regulatory labeling for your pharma labeling services. Let us guide you in responsible labeling and protect your product. - [Metabolic Disorder Studies](https://www.celerion.com/expertise/therapeutic-expertise-areas/metabolic-disorder-studies/) - Through years of experience in metabolic clinical trials, Celerion has been able to advance the range of metabolic services offered. Discover how sample collection, medical imaging, and glucose analysis will assist your product's market penetration. - [Respiratory Disease Research](https://www.celerion.com/expertise/therapeutic-expertise-areas/respiratory-disease-research/) - Celerion offers a solution for respiratory CRO services by being a member of the UK's Translational Research Partnership in Respiratory. Access greater laboratory capabilities, lung imaging techniques, and expedite decision making for your respiratory clinical trials. - [Rifampin Alternatives for DDI Studies in Response to Nitrosamine Impurities](https://www.celerion.com/rifampin-alternatives/) - With over 50 years of experience and expertise in conducting early clinical research, we can be your full service clinical research organization (CRO) partner. - [Bioavailability/Bioequivalence](https://www.celerion.com/services/early-phase-service/bioavailability-bioequivalence/) - Celerion’s proven expertise in BA/BE studies combines regulatory compliance with operational excellence to deliver reliable, high-quality data for your generic drug development programs. Key Capabilities PROVEN REGULATORY EXCELLENCE with positive FDA inspection history, demonstrating consistent compliance, quality standards, and inspection readiness across all study types INVESTIGATIONAL PRODUCT RETENTION established on-site for supply chain reliability PROTOCOL - [Bioavailability/Bioequivalence-TEST](https://www.celerion.com/services/early-phase-service/bioavailability-bioequivalence-test/) - Celerion’s proven expertise in BA/BE studies combines regulatory compliance with operational excellence to deliver reliable, high-quality data for your generic drug development programs. Key Capabilities PROVEN REGULATORY EXCELLENCE with positive FDA inspection history, demonstrating consistent compliance, quality standards, and inspection readiness across all study types INVESTIGATIONAL PRODUCT RETENTION established on-site for supply chain reliability PROTOCOL - [Leadership Team](https://www.celerion.com/about/leadership/) - When you work with Celerion Management, you have access to over 100 years of collective hands-on experience. Meet our management team! - [Blog](https://www.celerion.com/about/blog/) - Stay current with Celerion's blog posts! - [Events](https://www.celerion.com/about/events/) - [add_eventon_list event_count=”6″ tile_count=”3″ show_limit=”yes” ux_val=”4″ event_past_future=”future” exp_so=”yes” tiles=”yes” tile_bg=”1″ tile_height=”648″ eventtop_style=”5″ hide_empty_months=”yes” hide_month_headers=”no” sep_month=”yes” number_of_months=”12″] Subscribe to receive updates. Stay up to date on the latest technologies, trends, and stories in clinical development and pharmacology. ENTER YOUR EMAIL(Required) Learn More About Celerion ABOUT US Why Choose Celerion SERVICES Our Services EXPERTISE Therapeutic & Specialty Expertise - [Celexus®: Real-Time Data Capture](https://www.celerion.com/innovations/celexus-real-time-data-capture/) - Celexus is Celerion's premier reporting tool that provides you a first look at your clinical research data, live, as it is collected in the lab. Find out how Celexus keeps you more informed about your study's progress. - [News](https://www.celerion.com/about/news/) - Stay current with Celerion's News & Events! - [Clinical Research Resources](https://www.celerion.com/resources/clinical-research-resources/) - Explore expert opinions on industry related trends and join Celerion to discuss recent developments in Biopharma! - [Data Management & Biometric Services](https://www.celerion.com/services/data-management-and-biometric-services/) - As a Biometrics CRO data management is one of our most valued services. Offering support in study design, modeling, data collection, analysis, and reporting - Celerion can provide the competitive advantage needed to achieve efficient collection of high-quality data. - [Contact](https://www.celerion.com/contact/) - Celerion is ready to help you with your needs swiftly and efficiently. Contact us to answer any questions, speak with a representative, or schedule a tour of our facilities! - [Cardiovascular Safety & Efficacy Trials](https://www.celerion.com/expertise/cardiovascular-safety-and-efficacy-trials/) - Utilizing years of experience in cardiovascular safety studies, we evaluate the safety of your emerging drug and help you navigate the ever-changing regulatory landscape. We offer full-service expertise with cardiovascular safety studies to get your product to market faster. - [Investigators](https://www.celerion.com/investigators/) - Potential Investigator Form Join the Celerion team as a Clinical Trial Investigator. We will work with you on the latest developments in medicine that can benefit your patients and enable you to contribute to advancing healthcare globally. We work in many different therapeutic areas, our key areas are: Cardiovascular, Metabolic, Oncology, Respiratory. Notice: JavaScript is - [Resources](https://www.celerion.com/resources/) - I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo. - [Electronic Trial Master File (eTMF) System](https://www.celerion.com/innovations/etmf/) - Explore Celerion's eTMF (electronic trial master file) solution and discover the benefit of having DIA TMF formatted and accessible to you and trial monitors through a secure portal that’s managed by our experienced eTMF personnel. Learn more today! - [Electronic Data Capture (EDC) Systems](https://www.celerion.com/innovations/electronic-data-capture-systems/) - With Celerion's EDC system, we are able to automate our data acquisition system and provide consistent data management and reporting capabilities in one centralized database. Discover how our EDC technology facilitates consistency of data collection across clinical sites, ensuring accurate and high-quality information. - [E-Lab Notebook: Digital Lab Data Management](https://www.celerion.com/innovations/e-lab-digital-lab-data-management/) - Labnotes is our custom, commercially available electronic laboratory notebook system. We developed this software to standardize documentation across our facilities and increase efficiency through centralized data storage. Learn how this solution means faster, more reliable research for your study. - [ClinQuick®: Rapid Clinical Trial Execution](https://www.celerion.com/innovations/clinquick-rapid-clinical-trial-execution/) - ClinQuick is Celerion's electronic data-acquisition system, developed for the purpose of making data collection and clinical operations more efficient and consistent across our facilities. See how our systems can ensure accurate, high-quality data for your drug development. - [Innovations](https://www.celerion.com/innovations/) - Innovation is a key part of what makes Celerion a leader within the pharma industry. Everyday we are leveraging new clinical research technology to provide faster, better research for you. Learn more about some of our innovative products and practices! - [Biosimilar Clinical Research](https://www.celerion.com/expertise/biosimilar-clinical-research/) - With nearly 50 years of experience in biologic drug development, we provide fast, reliable assessments of your biosimilars. Individual consultation and all-inclusive services are both available for biosimilar drugs, from preclinical to pivotal clinical studies. - [Therapeutic Expertise Areas](https://www.celerion.com/expertise/therapeutic-expertise-areas/) - When you work with Celerion, you gain access to decades of experience in several therapeutic areas in clinical trials. Our broad range of therapeutic expertise will prove to be a valuable asset - helping provide fast, innovative solutions for your drug’s development. - [Expertise](https://www.celerion.com/expertise/) - Between our comprehensive services and decades of therapeutic experience, we have the expertise to handle every aspect of your product's early development. Let us show you how we utilize our therapeutic areas of expertise in your drug's development. - [Biostatistical Analysis](https://www.celerion.com/services/data-management-and-biometric-services/biostatistical-analysis/) - At Celerion our highly qualified statisticians routinely perform a large number of biostatistics services to deliver high-quality, submission-ready data for regulatory agencies. Get accurate, detailed data for your drug with Celerion's clinical biostatistics. - [Modeling and Simulation Services](https://www.celerion.com/services/data-management-and-biometric-services/modeling-and-simulation/) - At Celerion, we offer a variety of services for modeling and simulation in drug development. Find out how we can enhance the developmental process by performing efficient, cost-effective and scientifically sound study designs. - [Drug Development & Regulatory Affairs Services](https://www.celerion.com/services/drug-development-and-regulatory-affairs-services/) - Our drug development & pharma regulatory affairs team help you navigate the complex process of clinical studies. Learn about our drug development services. - [Accessibility](https://www.celerion.com/accessibility/) - Website accessibility is an ongoing effort and we are actively taking steps to further enhance and improve the accessibility of Celerion. If you have difficulty using or accessing any element of this website, please contact us through our contact form on our website, call, or email and we will work with you to provide the - [Monitoring & Project Management Services](https://www.celerion.com/services/monitoring-project-management-services/) - At Celerion we leverage streamlined processes to save you valuable time and budget as part of our project management in clinical research. Experience the advantages of close coordination and efficient communication through the entire clinical trial management process. - [Early Phase Clinical Services](https://www.celerion.com/services/early-phase-service/) - During Phase 1 clinical trials, we dedicate time to collect information that is important for your drug. Explore how Celerion can get your product to the market faster with earlier go/no-go decisions. - [Our Global Locations](https://www.celerion.com/about/global-locations/) - Being a global CRO, Celerion is ready to provide resources and services for clients at an international scale. Take advantage of our global reach and let us show you the benefits of our broad network. ## Events - [2026 ObesityWeek](https://www.celerion.com/blog/event/2026-obesityweek/) - Washington, DC | NOV 14-17 Learn More - [2026 EBF Open Symposium](https://www.celerion.com/blog/event/2026-ebf-open-symposium/) - Barcelona, Spain | NOV 17-19 Learn More - [2026 Coresta Congress](https://www.celerion.com/blog/event/2026-coresta-congress/) - Victoria Falls, Zimbabwe | OCT 25-29 Learn More - [2026 AAPS PharmSci 360](https://www.celerion.com/blog/event/2026-aaps-pharmsci-360/) - New Orleans, LA | OCT 25-28 Learn More - [2026 Immunogenicity Summit](https://www.celerion.com/blog/event/2026-immunogenicity-summit/) - Alexandria, VA | OCT 19-22 Learn More - [2026 World ADC San Diego](https://www.celerion.com/blog/event/2026-world-adc-san-diego/) - San Diego, CA | OCT 12-15 Learn More - [2026 Mass Spectrometry & Advances in the Clinical Lab (MSACL) Annual Conference](https://www.celerion.com/blog/event/2026-mass-spectrometry-advances-in-the-clinical-lab-msacl-annual-conference/) - Montreal, Quebec, Canada | OCT 4-9 Learn More - [2026 ACCP Annual Meeting](https://www.celerion.com/blog/event/2026-accp-annual-meeting/) - Bethesda, MD | SEP 27-29 Learn More - [2026 21st Applied Pharmaceutical Analysis (APA) Conference](https://www.celerion.com/blog/event/2026-21st-applied-pharmaceutical-analysis-apa-conference/) - Sanofi, Cambridge | SEP 14-16 Learn More - [2026 EBF Autumn Focus Workshop](https://www.celerion.com/blog/event/2026-ebf-autumn-focus-workshop/) - Malaga, Spain | SEP 10-11 Learn More - [2026 AAPS Summer Scientific Forum](https://www.celerion.com/blog/event/2026-aaps-summer-scientific-forum/) - Columbus, OH | JUL 13-16 Learn More - [2026 AAPS NBC](https://www.celerion.com/blog/event/2026-aaps-nbc/) - San Diego, CA | MAY 11-14 | Booth #602 Learn More - [2026 American Society for Mass Spectrometry](https://www.celerion.com/blog/event/2026-american-society-for-mass-spectrometry/) - San Diego, CA | MAY 30- JUN 4 Learn More - [2026 EBF Spring Focus Workshop](https://www.celerion.com/blog/event/2026-ebf-spring-focus-workshop/) - Malaga, Spain | JUN 18-19 Learn More - [2026 CYTO](https://www.celerion.com/blog/event/2026-cyto/) - West Palm Beach, FL | JUN 6-10 Learn More - [2026 EBF YSS](https://www.celerion.com/blog/event/2026-ebf-yss/) - Belfort, Ghent (Belgium) | MAY 20-22 Learn More - [2026 SLAS Europe](https://www.celerion.com/blog/event/2026-slas-europe/) - Vienna, Austria | MAY 19-21 Learn More - [2026 Gyrolab Seminar](https://www.celerion.com/blog/event/2026-gyrolab-seminar/) - Munich, Germany | MAY 18-19 Learn More - [2026 Swiss Biotech Day](https://www.celerion.com/blog/event/2026-swiss-biotech-day/) - Congress Center Basel, Switzerland | MAY 4-5 Learn More - [2026 OCT New England](https://www.celerion.com/blog/event/2026-oct-new-england/) - Boston, MA | OCT 14-15 | Booth #85 Learn More - [2026 OCT Southern California](https://www.celerion.com/blog/event/2026-oct-southern-california/) - San Diego, CA | SEP 22-23 | Booth #38 Learn More - [2026 DIA Conference](https://www.celerion.com/blog/event/2026-dia-conference/) - Philadelphia, PA | JUN 14-18 | Booth #1527 Learn More - [2026 Society for Clinical Trials (SCT)](https://www.celerion.com/blog/event/2026-society-for-clinical-trials-sct/) - Phoenix, AZ | MAY 17-20 Learn More - [2026 OCT East Coast](https://www.celerion.com/blog/event/2026-oct-east-coast/) - New Brunswick, NJ | MAY 12-13 | Booth #49 Learn More - [2026 WRIB](https://www.celerion.com/blog/event/2026-wrib/) - Dallas, TX | APR 14-16 Learn More - [2026 EIP Summit](https://www.celerion.com/blog/event/2026-eip-summit/) - Lisbon, Portugal | MAR 16-19 Learn More - [2026 OCT West Coast](https://www.celerion.com/blog/event/2026-oct-west-coast/) - San Francisco, CA | FEB 11-12 | Booth #80 Learn More - [2026 SCOPE Summit](https://www.celerion.com/blog/event/2026-scope-summit/) - Orlando, FL | FEB 2-5 | Booth #1126 Learn More - [Clinical and Bioanalytical Aspects of Immune Monitoring via ELISpot](https://www.celerion.com/blog/event/clinical-and-bioanalytical-aspects-of-immune-monitoring-via-elispot/) - Abstract The Elispot (Enzyme-linked immunosorbent spot) assay is widely recognized as a powerful tool to monitor the immune system in response to therapeutic agents. Specifically, B-cell Elispot provides information on antigen specific antibody secreting cells, including memory B cells. In addition, antigen specific T-cell responses, most commonly measured by IFN-γ, yield valuable insight during clinical - [2025 REID Bioanalytical Forum](https://www.celerion.com/blog/event/2025-reid-bioanalytical-forum/) - [Boston Society Gene & Cell Therapy Conference](https://www.celerion.com/blog/event/boston-society-gene-cell-therapy-conference/) - [2025 ACCP Annual Meeting](https://www.celerion.com/blog/event/2025-accp-annual-meeting/) - [AAPS PharmSci 360 (2025)](https://www.celerion.com/blog/event/aaps-pharmsci-360-2025/) - [AAPS NBC](https://www.celerion.com/blog/event/aaps-nbc/) - [OCT New England (2025)](https://www.celerion.com/blog/event/oct-new-england-2025/) - [OCT Southern California (2025)](https://www.celerion.com/blog/event/oct-southern-california-2025/) - [EACPT (2025)](https://www.celerion.com/blog/event/eacpt-2025/) - [DIA (2025)](https://www.celerion.com/blog/event/dia-2025/) - [ASCPT (2025)](https://www.celerion.com/blog/event/ascpt-2025/) - [OCT East Coast (2025)](https://www.celerion.com/blog/event/oct-east-coast-2025/) - [WRIB 2025](https://www.celerion.com/blog/event/wrib-2025/) - [EIP 2025](https://www.celerion.com/blog/event/eip-2025/) - [Zurich Life Science Day 2025](https://www.celerion.com/blog/event/zurich-life-science-day-2025/) - [OCT West Coast 2025](https://www.celerion.com/blog/event/oct-west-coast-2025/) - [16th Annual SCOPE Summit 2025](https://www.celerion.com/blog/event/16th-annual-scope-summit-2025/) - [Immunogenicity Summit](https://www.celerion.com/blog/event/immunogenicity-summit/) - [Pharmaceutical & BioScience Society (PBSS)](https://www.celerion.com/blog/event/pharmaceutical-bioscience-society-pbss/) - [Drug-Drug Interaction Happy Hour & Dinner: Best Practices for Cocktail and DDI Studies](https://www.celerion.com/blog/event/drug-drug-interaction-happy-hour-dinner-best-practices-for-cocktail-and-ddi-studies/) - [EBF Open Symposium](https://www.celerion.com/blog/event/ebf-open-symposium/) - [European Society Of Gene And Cell Therapy Annual Congress (ESGCT)](https://www.celerion.com/blog/event/european-society-of-gene-and-cell-therapy-annual-congress-esgct/) - [AAPS PharmSci 360](https://www.celerion.com/blog/event/aaps-pharmsci-360/) - [European Society for Clinical Cell Analysis (ESCCA)](https://www.celerion.com/blog/event/european-society-for-clinical-cell-analysis-escca/) - [EBF Autumn Focus Workshop 2024 (Vaccine Assays)](https://www.celerion.com/blog/event/ebf-autumn-focus-workshop-2024-vaccine-assays/) - [OCT New England (2024)](https://www.celerion.com/blog/event/oct-new-england-2024/) - [OCT Southern California (2024)](https://www.celerion.com/blog/event/oct-southern-california-2024/) - [AAPS Summer Scientific Forum (2024)](https://www.celerion.com/blog/event/aaps-summer-scientific-forum-2024/) - [ON Helix](https://www.celerion.com/blog/event/on-helix/) - [PCMG ASSEMBLY 2024](https://www.celerion.com/blog/event/pcmg-assembly-2024/) - [AAV8 Shedding Assay to Support Gene Therapy Clinical Trials](https://www.celerion.com/blog/event/aav8-shedding-assay-to-support-gene-therapy-clinical-trials/) - [DIA 2024 Global Annual Meeting](https://www.celerion.com/blog/event/dia-2024-global-annual-meeting/) - [Pharmaceutical & Bioscience Society](https://www.celerion.com/blog/event/pharmaceutical-bioscience-society/) - [Boston Society Gene and Cell Therapy Conference](https://www.celerion.com/blog/event/boston-society-gene-and-cell-therapy-conference/) - [EIP | European Immunogenicity Platform](https://www.celerion.com/blog/event/eip-european-immunogenicity-platform/) - 15th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals - [OCT East Coast | 15th Annual Conference](https://www.celerion.com/blog/event/oct-east-coast-15th-annual-conference/) - Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget - [2024 AAPS National Biotechnology Conference](https://www.celerion.com/blog/event/2024-aaps-national-biotechnology-conference/) - [WRIB | 18th Annual Conference](https://www.celerion.com/blog/event/wrib-18th-annual-conference/) - The 18th WRIB (Workshops on Recent Issues in Bioanalysis) will be built on the success of the previous meetings, especially the 17th WRIB where 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to discuss current topics of interest in bioanalysis. High Quality, better compliance to regulations and scientific excellence have always been - [ASCPT 2024 Annual Meeting](https://www.celerion.com/blog/event/ascpt-2024-annual-meeting/) - The ASCPT 2024 Annual Meeting will be held as an in-person event March 27-29, at the Broadmoor in Colorado Springs, CO. Registrants for the in-person meeting will enjoy reuniting with friends and colleagues face-to-face, with more time to network. - [SCOPE Summit 2024 | 15th Annual](https://www.celerion.com/blog/event/scope-summit-2024-15th-annual/) - Clinical trials and clinical research are essential for advancing medical knowledge, improving patient care, and developing new treatments and therapies for the patients who need them. Execution of this vital work requires collaboration, innovation, and strategic decision-making. Now in its 15th year of fostering these joint efforts to advance our medical knowledge inclusive of all - [16th Annual Outsourcing in Clinical Trials West Coast 2024](https://www.celerion.com/blog/event/16th-annual-outsourcing-in-clinical-trials-west-coast-2024/) - Arena International are delighted to announce Outsourcing in Clinical Trials West Coast will be returning to Burlingame for the 16th annual event on February 6th & 7th 2024! You can visit us at booth #81. This conference will bring leading industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and - [Drug Labeling Studies in Clinical Pharmacology: Recent FDA/EMA Updates](https://www.celerion.com/blog/event/drug-labeling-studies-in-clinical-pharmacology-recent-fda-ema-updates/) - Tuesday, October 24, 2023 @ 11am – 12pm EDT During clinical development, new drug candidates undergo a series of key studies aiming to establish optimal treatment doses and dosing regimens and to confirm drug efficacy. Accompanying these principle clinical trials, a variety of ancillary studies — often referred to as drug labeling or new drug - [16th EBF Open Symposium](https://www.celerion.com/blog/event/16th-ebf-open-symposium/) - EBF was founded in 2006 at the initiative of 12 pharmaceutical companies. The goal was to create a platform for discussions around science, day-to-day procedures, business tools, technologies and last but not least regulatory issues. Until 2010, EBF membership was limited to pharmaceutical research and development companies with bioanalytical activities in Europe. From 2011 onwards, - [OCT New England](https://www.celerion.com/blog/event/oct-new-england/) - The 15th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations. This two day programme will feature three streams on Clinical Operations and Outsourcing, Clinical Technology and Innovation, and Patient Recruitment and - [OCT Southern California](https://www.celerion.com/blog/event/oct-south/) - Arena International are delighted to announce Outsourcing in Clinical Trials Southern California will be returning to La Jolla on the 26th-27th September 2023! For this years event, the conference will be focused on interactive discussions to provide insight into the current major operational issues with running clinical trials in the coming years. Don’t miss out - [Continuing the Conversation: Audience Questions from ASCPT Journal Family Webinar “Alternatives for Rifampin as a CYP3A Inducer in DDI Studies in View of N-Nitrosamine Impurity Issues”](https://www.celerion.com/blog/event/continuing-the-conversation/) - [AAV Vector Shedding Assay— Best Practices in Clinical Gene Therapy Method Development](https://www.celerion.com/blog/event/aav-vector-shedding-assay-best-practices-in-clinical-gene-therapy-method-development/) - Tuesday, June 20, 2023 @ 11am – 12pm EDT - [Alternatives for Rifampin as a CYP3A Inducer in DDI Studies in View of N-Nitrosamine Impurity Issues](https://www.celerion.com/blog/event/alternatives-for-rifampin-as-a-cyp3a-inducer-in-ddi-studies-in-view-of-n-nitrosamine-impurity-issues/) - [DIA 2023](https://www.celerion.com/blog/event/dia-2023/) - The DIA 2023 Global Annual Meeting invites industry, regulatory government, academics, and patients to network, problem-solve, and discuss global and local challenges facing the life sciences community. Hosted in Boston, DIA 2023 will amplify different perspectives while highlighting expertise across the globe to reimagine current processes that better enhance health and well-being. - [WRIB 2023](https://www.celerion.com/blog/event/wrib-2023/) - The 17th WRIB (Workshops on Recent Issues in Bioanalysis) is built on the success of the previous meetings, especially the 16th WRIB where over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to discuss current topics of interest in bioanalysis. High Quality, better compliance to regulations and scientific excellence have always been - [OCT East Coast 2023](https://www.celerion.com/blog/event/oct-east-coast-2023/) - Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget Join us for a two day event filled with case studies, panel discussion and face to face networking opportunities around clinical operations, technology and innovation, and data management. - [OCT Europe 2023](https://www.celerion.com/blog/event/oct-europe-2023/) - Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! For the 13th Annual event, our flagship European clinical show will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials. - [ASCPT Conference 2023](https://www.celerion.com/blog/event/2023-ascpt-conference/) - The ASCPT 2023 Annual Meeting will be held as an in-person event with an online component, March 22-24, at the Hyatt Regency in Atlanta, GA. Registrants for the in-person meeting will enjoy reuniting with friends and colleagues face-to-face, with more time to network. View the Preliminary Program for details on the Pre-Conference event and three - [OCT Israel 2023](https://www.celerion.com/blog/event/oct-israel-2023/) - The Outsourcing in Clinical Trials & Clinical Trial Supply Israel will bring clinical trial professionals from big and small pharma companies and biotechs to uncover new technologies and processes to optimize their clinical and outsourcing operations. The two day program will take a holistic approach to the latest challenges and innovations in clinical operations, such - [OCT West Coast 2023](https://www.celerion.com/blog/event/oct-west-coast/) - Arena International are delighted to announce Outsourcing in Clinical Trials West Coast will be returning to Burlingame for the annual event on March 1st & 2nd 2023! Day 1 will kick off with a talk on designing a playbook for how to handle an undesirable CRO-Sponsor partnership, followed by a Keynote Panel allowing attendees to - [SCOPE Summit 2023](https://www.celerion.com/blog/event/scope-summit/) - Now more than ever, the important work of this clinical research community requires collaboration and innovation. In its 14th year of fostering these goals, SCOPE Summit 2023 will take place February 6-9, 2023 in Orlando, FL at the Rosen Shingle Creek, over four stimulating days of in-depth discussions in 28 different conferences, 3 plenary keynote - [NASH Summit](https://www.celerion.com/blog/event/nash-summit/) - There has been a rise and fall of investment in NASH in the wake of highly demanding biopsy endpoints and late-stage clinical setbacks. However, a surge of interest in approaching metabolic syndrome more holistically, pivotal readouts in GLP-1 receptor agonists for the treatment of obesity, and trailblazing approaches to innovative trial design have resurrected and - [EBF Conference](https://www.celerion.com/blog/event/ebf-conference/) - EBF was founded in 2006 at the initiative of 12 pharmaceutical companies. The goal was to create a platform for discussions around science, day-to-day procedures, business tools, technologies and last but not least regulatory issues. Until 2010, EBF membership was limited to pharmaceutical research and development companies with bioanalytical activities in Europe. From 2011 onwards, - [Webinar - Nitrosamine Impurities in Rifampin – What Does it Mean for Your DDI Study?](https://www.celerion.com/blog/event/nitrosamine-impurities-in-rifampin-what-does-it-mean-for-your-ddi-study/) - N-Nitrosamine impurity findings in marketed formulations of rifampin have disrupted drug development. As a strong cytochrome P450 3A4 (CYP3A4) inducer, rifampin was regularly co-administered with investigational products during pharmacokinetic drug-drug interaction studies. However, due to recent impurity issues, its application in these studies has been suspended in both the US and EU. This webinar will - [Best Practices for Successful Phase 1 Studies: Minimizing Risk and Regulatory Pitfalls Clinical Discussion Program](https://www.celerion.com/blog/event/best-practices-for-successful-phase-1-studies-minimizing-risk-and-regulatory-pitfalls-clinical-discussion-program/) - You are invited to attend Celerion’s Clinical Discussion Program in San Diego, hosted by our own Stephanie Hagen, Senior Director of Business Development! Hear from Phil Bach, Vice President of Global Clinical Research, on “Best Practices for Successful Phase 1 Studies: Minimizing Risk and Regulatory Pitfalls”. We anticipate an engaging and interactive discussion. Space is - [Onsite Pharmacy Compounding for Your Phase 1 Clinical Study](https://www.celerion.com/blog/event/onsite-pharmacy-compounding-for-your-phase-1-clinical-study/) - Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical, Drug Discovery & Development 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central) 60 min - [OCT New England 2022](https://www.celerion.com/blog/event/oct-new-england-2022/) - [OCT Sourthern California 2022](https://www.celerion.com/blog/event/oct-sourthern-california-2022/) - [WRIB](https://www.celerion.com/blog/event/wrib/) - 16th WRIB will take place on September 26-30, 2022 in Atlanta, GA, USA. In case you are not sure about travel, remote attendance option will also be made available, and you can switch between the in-person and remote options anytime. - [DIA 2022](https://www.celerion.com/blog/event/dia-2022/) - Reconnect with Your Life Sciences Community Live in Chicago Receive Early Bird Pricing until January 28 EXPLORE Recognizing and adapting to a new era of global change and uncertainty, DIA's key tenets remain unchanged. Join us in Chicago June 19-23, 2022 Stop by our booth #2409! Celerion’s Director of Scientific Affairs, Sabina Paglialunga, will be - [Reid Bioanalytical Forum](https://www.celerion.com/blog/event/reid-bioanalytical-forum-2/) - EVENT DETAILS DATE: June 13, 2022 - June 16, 2022 WEBSITE: https://na.eventscloud.com/ereg/newreg.php?eventid=553115 LOCATION: The Cambridge Belfry, Cambourne, United Kingdom, Europe - [OCT East Coast 2022](https://www.celerion.com/blog/event/oct-east-coast-2022/) - [OCT West Coast 2022](https://www.celerion.com/blog/event/oct-west-coast-2022/) - Hyatt Regency San Francisco Airport 15th-16th February, 2022 - [Outsourcing in Clinical Trials Southern California 2021 (Arena International)](https://www.celerion.com/blog/event/outsourcing-in-clinical-trials-southern-california-2021-arena-international/) - Arena International are delighted to announce the return of Outsourcing in Clinical Trials Southern California this December for its 8th Annual event! Our 2021 programme boasts two full streams; Clinical Operations & Outsourcing Clinical Trial Technology & Innovation Attendees will hear from AbbVie, Pfizer, Arena Pharmaceuticals, Bristol Myers Squibb, ClearFlow, Daré Bioscience and many more. Mary - [EBF Barcelona](https://www.celerion.com/blog/event/ebf-barcelona/) - [WRIB Orlanda Florida](https://www.celerion.com/blog/event/wrib-orlanda-florida/) - [ARENA OCT Southern California 2021](https://www.celerion.com/blog/event/arena-oct-southern-california/) - [REID Bioanalytical Forum 2021](https://www.celerion.com/blog/event/reid-bioanalytical-forum/) - [DIA 2021](https://www.celerion.com/blog/event/dia/) - [ARENA OCT South East 2021](https://www.celerion.com/blog/event/arena-oct-south-east/) - [Webinar - Bioanalytical Support of Biosimilars: Expect the Unexpected](https://www.celerion.com/blog/event/webinar-bioanalytical-support-of-biosimilars-expect-the-unexpected/) - [ARENA OCT East Coast 2021](https://www.celerion.com/blog/event/oct-east-coast-2021/) - [ASCPT 2021](https://www.celerion.com/blog/event/ascpt-2021/) - [OCT West 2021](https://www.celerion.com/blog/event/oct-west-2021/) - [EBF 2020](https://www.celerion.com/blog/event/ebf-2020/) - [World Vaccine Congress Europe](https://www.celerion.com/blog/event/world-vaccine-congress-europe/) - [Outsourcing in Clinical Trials USA](https://www.celerion.com/blog/event/outsourcing-in-clinical-trials-usa/) - [LaunchBio Webinar](https://www.celerion.com/blog/event/launchbio-webinar/) - [2020 DIA](https://www.celerion.com/blog/event/2020-dia/) - Booth #527 - [2020 OCT East Coast](https://www.celerion.com/blog/event/2020-oct-east-coast/) - Booth #49 - [2020 OCT Europe](https://www.celerion.com/blog/event/2020-oct-europe/) - Booth #29 - [2020 EASL](https://www.celerion.com/blog/event/2020-easl/) - Booth #74 - [2020 World Vaccine Congress](https://www.celerion.com/blog/event/2020-world-vaccine-congress/) - Booth #218 - [2020 WRIB](https://www.celerion.com/blog/event/2020-wrib/) - Booth #41 - [ADME 101: Lessons on Running a Successful Clinical Mass Balance Trial](https://www.celerion.com/blog/event/adme-101-lessons-on-running-a-successful-clinical-mass-balance-trial/) ## Resources - [Sinus Arrest Associated with COVID-19 Nasalpharyngeal Swab Procedure](https://www.celerion.com/resource/sinus-arrest-associated-with-covid-19-nasalpharyngeal-swab-procedure/) - [Application of Ophthalmic Examinations In Early Phase Studies](https://www.celerion.com/resource/application-of-ophthalmic-examinations-in-early-phase-studies/) - [Application of Echocardiograms In Early Phase Studies](https://www.celerion.com/resource/application-of-echocardiograms-in-early-phase-studies/) - [Celerion Overview Brochure](https://www.celerion.com/resource/celerion-overview-brochure/) - [𝗧𝗵𝗲 𝗠𝗮𝗻𝘆 𝗙𝗮𝗰𝗲𝘀 𝗼𝗳 𝗕𝗶𝗼𝗲𝗾𝘂𝗶𝘃𝗮𝗹𝗲𝗻𝗰𝗲](https://www.celerion.com/resource/𝗧𝗵𝗲-𝗠𝗮𝗻𝘆-𝗙𝗮𝗰𝗲𝘀-𝗼𝗳-𝗕𝗶/) - https://vimeo.com/1137847355?share=copy&fl=sv&fe=ci - [No More Guesswork: The Ideal eGFR Formula for Optimized Healthy Volunteer Study Enrollment](https://www.celerion.com/resource/no-more-guesswork-the-ideal-egfr-formula-for-optimized-healthy-volunteer-study-enrollment/) - [QT Myopia and Cardiac Safety](https://www.celerion.com/resource/qt-myopia-and-cardiac-safety/) - [Challenges in Biosimilar Bioanalytical Assays and Sample Processing](https://www.celerion.com/resource/challenges-in-biosimilar-bioanalytical-assays-and-sample-processing/) - https://youtu.be/Z5bGdnZROX8 - [Seeing Through the MIST: Metabolite Identification and Profiling Strategies](https://www.celerion.com/resource/seeing-through-the-mist-metabolite-identification-and-profiling-strategies/) - https://youtu.be/QjQ1ma_4cFs - [Celerion’s Zurich Bioanalytical Lab Tour](https://www.celerion.com/resource/celerions-zurich-bioanalytical-lab-tour/) - [Making Virtual Trials a Reality](https://www.celerion.com/resource/making-virtual-trials-a-reality/) - [Back to Basics: pH-Dependent Drug Interactions with Acid Reducing Agents](https://www.celerion.com/resource/back-to-basics-ph-dependent-drug-interactions-with-acid-reducing-agents/) - [High Throughput Bioanalytical Analysis](https://www.celerion.com/resource/high-throughput-bioanalytical-analysis/) - [EU Biotech Needs First-in-Human FDA Support](https://www.celerion.com/resource/eu-biotech-needs-first-in-human-fda-support-2/) - [IND Support for Asian Biotech](https://www.celerion.com/resource/ind-support-for-asian-biotech-2/) - [Partnering with Biotechnology Companies](https://www.celerion.com/resource/partnering-with-biotechnology-companies/) - [Partnering with Large Pharmaceutical Companies](https://www.celerion.com/resource/partnering-with-large-pharmaceutical-companies/) - [SARS-CoV-2 Viral RNA Load is Associated with the Number of COVID-19 Symptoms Experienced in Mildly Symptomatic Adults: An Observational Study](https://www.celerion.com/resource/sars-cov-2-viral-kinetic-observational-study/) - [SARS-CoV-2 PCR Assay Validation – Nasopharyngeal vs Saliva Sample Collection](https://www.celerion.com/resource/sars-cov-2-bioanalytical-pcr-assay-validation/) - [Rifampin Drug-Drug-Interaction Studies; Reflections on The Nitrosamine Impurities Issue](https://www.celerion.com/resource/rifampin-drug-drug-interaction-studies-reflections-on-the-nitrosamine-impurities-issue/) - View Article - [2022 EBF YSS – Tackling Sample Loss and Lot-to-Lot Variability During Protein Labeling](https://www.celerion.com/resource/protein-labelling/) - [2022 EUFEPS – Overcoming Rifampin Impurity Challenges for DDI Studies: Phenytoin as an Alternative](https://www.celerion.com/resource/overcoming-rifampin-impurity-challenges-for-ddi-studies-phenytoin-as-an-alternative/) - [2021 Oxford Biomarkers – Biomarkers: Biology vs Bioanalysis](https://www.celerion.com/resource/2021-oxford-biomarkers-biomarkers-biology-vs-bioanalysis/) - [2018 Land O’Lakes – Approaches to Improve Sensitivity and Drug Tolerance by Reducing Target Interference During Development of an Anti-Drug Antibody Assay](https://www.celerion.com/resource/2018-land-olakes-approaches-to-improve-sensitivity-and-drug-tolerance-by-reducing-target-interference-during-development-of-an-anti-drug-antibody-assay/) - [2018 Land O’Lakes – Development of PK and Anti-Drug Antibody Assay with High Drug Tolerance for Bevacizumab (Avastin®) and its Biosimilars](https://www.celerion.com/resource/2018-land-olakes-development-of-pk-and-anti-drug-antibody-assay-with-high-drug-tolerance-for-bevacizumab-avastin-and-its-biosimilars/) - [2018 ADA – Evaluating the Distribution of Diabetes and Prediabetes in Arizona’s Maricopa County](https://www.celerion.com/resource/2018-ada-evaluating-the-distribution-of-diabetes-and-prediabetes-in-arizonas-maricopa-county/) - [2022 DIA – SARS-CoV-2 Viral Levels and Antibody Response in Mildly Symptomatic and Asymptomatic Participants](https://www.celerion.com/resource/2022-dia-sars-cov-2-viral-levels-and-antibody-response-in-mildly-symptomatic-and-asymptomatic-participants/) - [Lessons Learned From 50+ Years of First-in-Human Clinical Experience](https://www.celerion.com/resource/lessons-learned-from-50-years-of-first-in-human-clinical-experience/) - [Product Labeling Studies](https://www.celerion.com/resource/product-labeling-studies-2/) - [Overcoming Rifampin Impurity Challenges for DDI Studies: Phenytoin as an Alternative](https://www.celerion.com/resource/overcoming-rifampin-impurity-challenges-for-ddi-studies-phenytoin-as-an-alternative-2/) - [qPCR vs. ELISpot: Which Assay is Better to Assess Antigen-Specific IFN-γ Secretion in PBMCs?](https://www.celerion.com/resource/qpcr-vs-elispot/) - [A Dramatic Increase in Free Drug Tolerance Using PandA Compared to Standard Acid Dissociation](https://www.celerion.com/resource/dramatic-increase-in-free-drug-tolerance-using-p-and-a/) - [Assessing Trends in HbA1c Over 4 Years in Phoenix Metropolitan Area Ethnic Populations](https://www.celerion.com/resource/assessing-trends-in-hba1c-over-4-years/) - [Simultaneous Quantitation of δ9-Tetrahydrocannabinol, Cannabidiol and Their Metabolites in Human Plasma Coupled to a Highly Sensitive Method for Quantitation of Trace Amount of δ9-Tetrahydrocannabinol](https://www.celerion.com/resource/simultaneous-quantitation-of-δ9-tetrahydrocannabinol-cannabidiol-and-their-metabolites/) - [The Pioneering Tech Speeding Up Drug Development](https://www.celerion.com/resource/the-pioneering-tech-speeding-up-drug-development/) - [Prevalence of Baseline Cardiac Arrhythmias in Participants with Overweight or Obesity in Phase 1 Clinical Trials: Analysis of 24-Hour Holter Electrocardiogram Recordings](https://www.celerion.com/resource/prevalence-of-baseline-cardiac-arrhythmias-in-participants-with-overweight-or-obesity-in-phase-1-clinical-trials-analysis-of-24-hour-holter-electrocardiogram-recordings/) - [Refining Transporter DDI Studies with Endogenous Biomarkers](https://www.celerion.com/resource/refining-transporter-ddi-studies-with-endogenous-biomarkers/) - [The Impact of N-nitrosamine Impurities on Clinical Drug Development](https://www.celerion.com/resource/the-impact-of-n-nitrosamine-impurities-on-clinical-drug-development/) - [The Impact of N-nitrosamine Impurities on Clinical Drug Development: Drug-Drug Interaction Studies](https://www.celerion.com/resource/the-impact-of-n-nitrosamine-impurities-on-clinical-drug-development-drug-drug-interaction-studies/) - [Global Cell and Gene Therapy Services Overview](https://www.celerion.com/resource/global-cell-and-gene-therapy-services-overview/) - [Perpetrator or Victim: Evaluating Therapeutic Proteins in Drug-Drug Interaction Studies](https://www.celerion.com/resource/perpetrator-or-victim-evaluating-therapeutic-proteins-in-drug-drug-interaction-studies-2/) - [Women’s Health: Maximizing Study Design of Combined Oral Contraceptives Drug Interaction Studies](https://www.celerion.com/resource/womens-health-maximizing-study-design-of-combined-oral-contraceptives-drug-interaction-studies-2/) - [Impact of the FDA’s Revised Draft Guidance on Renal Impairment PK Studies—Trends, Challenges and Solutions](https://www.celerion.com/resource/impact-of-the-fdas-revised-draft-guidance-on-renal-impairment-pk-studies-trends-challenges-and-solutions/) - [Flushing Out Translational Excretion Data: How Well Do Nonclinical ADME Results Predict Clinical Findings?](https://www.celerion.com/resource/flushing-out-translational-excretion-data-how-well-do-nonclinical-adme-results-predict-clinical-findings/) - [Celerion: Accelerating Therapeutic Futures with Molecular Biology Services](https://www.celerion.com/resource/celerion-accelerating-therapeutic-futures-with-molecular-biology-services/) - [Celerion: Leading Your Research into the Future with Premium Flow Cytometry Services](https://www.celerion.com/resource/celerion-leading-your-research-into-the-future-with-premium-flow-cytometry-services/) - [Unraveling CYP3A Gut vs Liver Drug Metabolism and P-glycoprotein Activity](https://www.celerion.com/resource/unraveling-cyp3a-gut-vs-liver-drug-metabolism-and-p-glycoprotein-activity/) - [Preexisting Antibody Assays for Gene Therapy: Considerations on Patient Selection Cutoffs and Companion Diagnostic Requirements](https://www.celerion.com/resource/preexisting-antibody-assays-for-gene-therapy-considerations-on-patient-selection-cutoffs-and-companion-diagnostic-requirements/) - [Leaders in Bioequivalence and Bioavailability Studies](https://www.celerion.com/resource/leaders-in-bioequivalence-and-bioavailability-studies/) - [Leverage Our Renal/Hepatic PK Study Experience & Expertise](https://www.celerion.com/resource/leverage-our-renal-hepatic-pk-study-experience-expertise-2/) - [Food Effect Study Best Practices](https://www.celerion.com/resource/food-effect-study-best-practices/) - [Expert Drug-Drug Interaction Study Design and Conduct](https://www.celerion.com/resource/expert-drug-drug-interaction-study-design-and-conduct/) - [Pharmacokinetic and Pharmacodynamic Relationships of Intranasally Administered and Intramuscularly Injected Epinephrine](https://www.celerion.com/resource/pharmacokinetic-and-pharmacodynamic-relationships-of-intranasally-administered-and-intramuscularly-injected-epinephrine/) - [What to Expect from a Phenytoin Drug-Drug Interaction Study: Adverse Event Profiling and Safety Assessment](https://www.celerion.com/resource/what-to-expect-from-a-phenytoin-drug-drug-interaction-study-adverse-event-profiling-and-safety-assessment/) - [No Photosafety or Photoallergy Effect with MRX-5LBT (10%) Lidocaine Patch Administration](https://www.celerion.com/resource/no-photosafety-or-photoallergy-effect-with-mrx-5lbt-10-lidocaine-patch-administration/) - [AAV8 Shedding Assay to Support Gene Therapy Clinical Trials](https://www.celerion.com/resource/aav8-shedding-assay-to-support-gene-therapy-clinical-trials/) - [Food Effect, Gastric Emptying, ARA's, GLP-1 agonists](https://www.celerion.com/resource/food-effect-gastric-emptying-aras-glp-1-agonists/) - [Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations](https://www.celerion.com/resource/should-you-run-a-dedicated-tqt-study-sponsor-and-regulatory-considerations/) - [Optimizing Cell Viability in Cell Therapy: A Comparative Study of Whole Blood Sample Stabilization Techniques](https://www.celerion.com/resource/optimizing-cell-viability-in-cell-therapy-a-comparative-study-of-whole-blood-sample-stabilization-techniques/) - [Critical Reagent Characterization of Biotinylated Antibody Conjugates in a Flow Cytometry-Based Receptor Occupancy Assay](https://www.celerion.com/resource/critical-reagent-characterization-of-biotinylated-antibody-conjugates-in-a-flow-cytometry-based-receptor-occupancy-assay/) - [Low Cut Points: Where Has Our Biological Variability Gone?](https://www.celerion.com/resource/low-cut-points-where-has-our-biological-variability-gone/) - [Developing an Ultrasensitive PK Assay Using SIMOA: Step-by-Step to the Target](https://www.celerion.com/resource/developing-an-ultrasensitive-pk-assay-using-simoa-step-by-step-to-the-target/) - [Leverage Our Regulatory Experts for Pre-IND and IND Support](https://www.celerion.com/resource/leverage-our-regulatory-experts-for-pre-ind-and-ind-support/) - [The Rollercoaster Between Free Drug Tolerance and Target Interference in the Development of an Anti-Drug Antibody Assay](https://www.celerion.com/resource/the-rollercoaster-between-free-drug-tolerance-and-target-interference-in-the-development-of-an-anti-drug-antibody-assay/) - [A 13.2 mg Epinephrine Intranasal Spray Demonstrates Comparable Pharmacokinetics, Pharmacodynamics, and Safety to a 0.3 mg Epinephrine Autoinjector](https://www.celerion.com/resource/a-13-2-mg-epinephrine-intranasal-spray-demonstrates-comparable-pharmacokinetics-pharmacodynamics-and-safety-to-a-0-3-mg-epinephrine-autoinjector/) - [Phenytoin: A Safe and Potent Alternative to Rifampin as CYP3A Inducer in Drug-Drug-Interaction Studies](https://www.celerion.com/resource/phenytoin-a-safe-and-potent-alternative-to-rifampin-as-cyp3a-inducer-in-drug-drug-interaction-studies/) - [Predictive Value of Nonclinical ADME Findings for Clinical Excretion Routes](https://www.celerion.com/resource/predictive-value-of-nonclinical-adme-findings-for-clinical-excretion-routes/) - [Comprehensive Cardiovascular Safety and ECG Core Laboratory Services](https://www.celerion.com/resource/comprehensive-cardiovascular-safety-and-ecg-core-laboratory-services/) - [Innovative Approaches to Optimize Clinical Transporter Drug–Drug Interaction Studies](https://www.celerion.com/resource/innovative-approaches-to-optimize-clinical-transporter-drug-drug-interaction-studies/) - [Randomized Trial of Pharmacokinetic and Pharmacodynamic Effects of 13.2 mg Intranasal Epinephrine Treatment in Congestion](https://www.celerion.com/resource/randomized-trial-of-pharmacokinetic-and-pharmacodynamic-effects-of-13-2-mg-intranasal-epinephrine-treatment-in-congestion/) - [Leaders in Biosimilars](https://www.celerion.com/resource/leaders-in-biosimilars/) - [Celerion: Your Partner for High-Quality PBMC Processing & Clinical Site Training](https://www.celerion.com/resource/celerion-your-partner-for-high-quality-pbmc-processing-clinical-site-training/) - [Case Study: Bioanalytical Support of Oncology Studies](https://www.celerion.com/resource/case-study-bioanalytical-support-of-oncology-studies/) - [Patient-Screening in AAV Gene Therapy: Only High Anti-AAV Titers Impact Transduction and Efficacy](https://www.celerion.com/resource/patient-screening-in-aav-gene-therapy-only-high-anti-aav-titers-impact-transduction-and-efficacy/) - [Development of 24-Hour Rhythms in Cortisol Secretion Across Infancy](https://www.celerion.com/resource/development-of-24-hour-rhythms-in-cortisol-secretion-across-infancy/) - [The Rollercoaster Between Free Drug Tolerance and Target Interference in the Development of an Antidrug Antibody Assay](https://www.celerion.com/resource/the-rollercoaster-between-free-drug-tolerance-and-target-interference-in-the-development-of-an-antidrug-antibody-assay/) - [Automated Singlicate Biomarker Assay: Enhancing Assay Performance by Surrogate Matrix Optimization](https://www.celerion.com/resource/automated-singlicate-biomarker-assayenhancing-assay-performance-by-surrogate-matrix-optimization/) - [Leaders in Early Metabolic Disease Studies](https://www.celerion.com/resource/leaders-in-early-metabolic-disease-studies/) - [Clinical and Bioanalytical Support for Monoclonal Antibody Drugs](https://www.celerion.com/resource/clinical-and-bioanalytical-support-for-monoclonal-antibody-drugs/) - [Clinical and Bioanalytical Oligonucleotide Experience and Expertise](https://www.celerion.com/resource/clinical-and-bioanalytical-oligonucleotide-experience-and-expertise/) - [Peptide Drugs: Clinical & Bioanalytical Drug Development](https://www.celerion.com/resource/peptide-drugs-clinical-bioanalytical-drug-development/) - [Surfing the T Wave: A Primer on ECG T Wave Morphologies Encountered in Clinical Trials and Impact on the QT Interval and Patient Safety](https://www.celerion.com/resource/surfing-the-t-wave-a-primer-on-ecg-t-wave-morphologies-encountered-in-clinical-trials-and-impact-on-the-qt-interval-and-patient-safety/) - [ASCPT 2024 Abstract - MRX-5LBT Photosafety](https://www.celerion.com/resource/ascpt-2024-abstract-mrx-5lbt-photosafety/) - [A European Bioanalysis Forum Recommendation for Requiring a Context-of-Use Statement for Successful Development and Validation of Biomarker Assays](https://www.celerion.com/resource/a-european-bioanalysis-forum-recommendation-for-requiring-a-context-of-use-statement-for-successful-development-and-validation-of-biomarker-assays/) - [Immune Challenge Models For Drug Development](https://www.celerion.com/resource/immune-challenge-models-for-drug-development/) - [Pulmonary Sampling Techniques & Sample Analysis](https://www.celerion.com/resource/pulmonary-sampling-techniques-sample-analysis/) - [Supporting Inhaled Drug Development](https://www.celerion.com/resource/supporting-inhaled-drug-development/) - [Clinical and Bioanalytical Biologics Experience & Expertise](https://www.celerion.com/resource/clinical-and-bioanalytical-biologics-experience-expertise/) - [Drug Development for Women’s & Men’s Health](https://www.celerion.com/resource/drug-development-for-womens-mens-health/) - [Predictive Value of Nonclinical ADME Findings for Clinical Excretion Routes](https://www.celerion.com/resource/predictive-value-of-nonclinical-adme-findings-for-clinical-excretion-routes-2/) - [Evaluating Singlicate Analysis for Cell-Based Neutralizing Antibody Assays](https://www.celerion.com/resource/evaluating-singlicate-analysis-for-cell-based-neutralizing-antibody-assays/) - [Advancing Whole Blood Stabilization Techniques for Immunological Analytical Outcomes](https://www.celerion.com/resource/advancing-whole-blood-stabilization-techniques-for-immunological-analytical-outcomes/) - [Advancing PBMC Isolation for ELISPOT Analysis](https://www.celerion.com/resource/advancing-pbmc-isolation-for-elispot-analysis/) - [Bringing Unstable Flow Cytometry Assays Closer to the Patient](https://www.celerion.com/resource/bringing-unstable-flow-cytometry-assays-closer-to-the-patient/) - [Improving Drug Tolerance in Anti-Drug Antibody (ADA) Assay Using PandA Method - Case Studies](https://www.celerion.com/resource/improving-drug-tolerance-in-anti-drug-antibody-ada-assay-using-panda-method-case-studies/) - [A Cocktail DDI Study](https://www.celerion.com/resource/a-cocktail-ddi-study/) - [Safety, Tolerability and PK of SM17 in Healthy Volunteers](https://www.celerion.com/resource/safety_tolerability_and-pk-of-sm17-in-healthy-volunteers/) - [Predictive Value of Nonclinical ADME Findings for Clinical Excretion Routes](https://www.celerion.com/resource/predictive-value-of-nonclinical-adme-findings-for-clinical-excretion-routes-3/) - [Best Practices for Receptor Occupancy Assays in Clinical Sample Analysis](https://www.celerion.com/resource/best-practices-for-receptor-occupancy-assays-in-clinical-sample-analysis/) - [Optimization of Critical Steps for Measuring Immunomodulatory Therapeutic PD Effects](https://www.celerion.com/resource/optimization-of-critical-steps-for-measuring-immunomodulatory-therapeutic-pd-effects/) - [Supporting GLP-1 Receptor Agonist & Weight Reduction Drug Development](https://www.celerion.com/resource/supporting-glp-1-receptor-agonist-weight-reduction-drug-development/) - [Bioanalytical Brochure](https://www.celerion.com/resource/bioanalytical-brochure-2/) - [A Renal Impairment Study Evaluating Plasma and Intracellular (PBMC) Pharmacokinetics](https://www.celerion.com/resource/a-renal-impairment-study-evaluating-plasma-and-intracellular-pbmc-pharmacokinetics/) - [Navigating Enrollment & Central Lab Challenges in a Large Pharmacokinetic Study with Severe Renal Impairment](https://www.celerion.com/resource/navigating-enrollment-central-lab-challenges-in-a-large-pharmacokinetic-study-with-severe-renal-impairment/) - [A Hepatic Impairment Study for a Drug with a Long Half-Life; Aggressive Enrollment Timelines at a European Site](https://www.celerion.com/resource/a-hepatic-impairment-study-for-a-drug-with-a-long-half-life-aggressive-enrollment-timelines-at-a-european-site/) - [De-Risking and Optimizing First-in- Human Studies](https://www.celerion.com/resource/de-risking-and-optimizing-first-in-human-studies/) - [Lumbar Puncture & Cerebrospinal Fluid Sampling](https://www.celerion.com/resource/lumbar-puncture-cerebrospinal-fluid-sampling/) - [A Creative Cocktail Drug-Drug Interaction Study to Evaluate the Effect of Sparsentan at Steady State on the PK of CYP & Transporter Substrates](https://www.celerion.com/resource/a-creative-cocktail-drug-drug-interaction-study-to-evaluate-the-effect-of-sparsentan-at-steady-state-on-the-pk-of-cyp-transporter-substrates/) - [AAPS eChalk Talk - Saliva - A Reliable Sample Matrix in Bioanalytics](https://www.celerion.com/resource/aaps-echalk-talk-saliva-a-reliable-sample-matrix-in-bioanalytics/) - https://youtu.be/dH9V5YPzYgY - [Power to the People: Estimating Sample Sizes for No Effect Drug-Drug Interaction Studies with Sensitive CYP and Transporter Substrates](https://www.celerion.com/resource/power-to-the-people-estimating-sample-sizes-for-no-effect-drug-drug-interaction-studies-with-sensitive-cyp-and-transporter-substrates/) - [A Fully Automated Workflow for Gyrolab Assays](https://www.celerion.com/resource/a-fully-automated-workflow-for-gyrolab-assays/) - [Drug Absorption & Impact of Food, Gastric pH, Gastric Emptying and GLP-1 Agonists](https://www.celerion.com/resource/drug-absorption-impact-of-food-gastric-ph-gastric-emptying-and-glp-1-agonists/) - https://youtu.be/oN8b2oUSjp4 - [Drug-Drug Interaction Studies Recommended for Novel GLP-1 Receptor Agonists](https://www.celerion.com/resource/drug-drug-interaction-studies-recommended-for-novel-glp-1-receptor-agonists/) - https://youtu.be/gMluQweDqxw - [Onsite Pharmacy Compounding for Your Phase 1 Clinical Study Webinar](https://www.celerion.com/resource/onsite-pharmacy-compounding-for-your-phase-1-clinical-study-webinar/) - https://www.youtube.com/watch?v=NiPmjAL4bLY - [AAV Vector Shedding Assay— Best Practices in Clinical Gene Therapy Method Development](https://www.celerion.com/resource/aav-vector-shedding-assay-best-practices-in-clinical-gene-therapy-method-development/) - https://www.youtube.com/watch?v=ZZ_-zmCWA94 - [Phil Bach, Executive Vice President, Celerion goes one-on-one with Clinical Leader](https://www.celerion.com/resource/phil-bach-executive-vice-president-celerion-goes-one-on-one-with-clinical-leader/) - https://www.youtube.com/watch?v=kbOXlTtMS7c - [Alternatives for Rifampin as a CYP3A Inducer in DDI Studies in View of N-Nitrosamine Impurity Issues](https://www.celerion.com/resource/alternatives-for-rifampin-as-a-cyp3a-inducer-in-ddi-studies-in-view-of-n-nitrosamine-impurity-issues/) - https://vimeo.com/836648123/081549a3bf - [Continuing the Conversation: Audience Questions from ASCPT Journal Family Webinar “Alternatives for Rifampin as a CYP3A Inducer in DDI Studies in View of N-Nitrosamine Impurity Issues.”](https://www.celerion.com/resource/continuing-the-conversation-audience-questions-from-ascpt-journal-family-webinar-alternatives-for-rifampin-as-a-cyp3a-inducer-in-ddi-studies-in-view-of-n-nitrosamine-impurity-issues/) - [Drug Labeling Studies in Clinical Pharmacology: Recent FDA/EMA Updates](https://www.celerion.com/resource/drug-labeling-studies-in-clinical-pharmacology-recent-fda-ema-updates/) - https://www.youtube.com/watch?v=gXCY5idW388 - [Celerion’s Lincoln Bioanalytical Lab Tour](https://www.celerion.com/resource/celerions-bioanalytical-labs-tour/) - https://www.youtube.com/watch?v=WDCo7zqFE5s&t=12s - [Nitrosamine Impurities in Rifampin – What Does it Mean for Your Drug-Drug Interaction (DDI) Study](https://www.celerion.com/resource/nitrosamine-impurities-in-rifampin-what-does-it-mean-for-your-drug-drug-interaction-ddi-study/) - https://www.youtube.com/watch?v=7vSm1tPYjD0 - [AAV8 Shedding Assay to Support Gene Therapy Clinical Trials](https://www.celerion.com/resource/aav8-shedding-assay-to-support-gene-therapy-clinical-trials-2/) - https://youtu.be/izIRuFqa-_U - [Onsite Pharmacy Compounding for Your Phase 1 Clinical Study](https://www.celerion.com/resource/onsite-pharmacy-compounding-for-your-phase-1-clinical-study/) - https://youtu.be/bOfNrLSwdao ## Categories - [News](https://www.celerion.com/blog/category/news/) - [Blog](https://www.celerion.com/blog/category/blog/) - [Recruitment](https://www.celerion.com/blog/category/recruitment/) ## Tags - [respiratory disease](https://www.celerion.com/blog/tag/respiratory-disease/) - [renal / hepatic insufficiency](https://www.celerion.com/blog/tag/renal-hepatic-insufficiency/) - [Celexus](https://www.celerion.com/blog/tag/celexus/) - [EDC](https://www.celerion.com/blog/tag/edc/) - [early phase services solutions](https://www.celerion.com/blog/tag/early-phase-services-solutions/) - 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