Celerion, Inc.

LINCOLN, Neb.--( 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 <71>) and dose formulation analysis. Per FDA guidance, pharmaceutical products intended for parenteral administration must undergo sterility testing and provide results that meet stringent safety standards before reaching patients. Additionally, laboratory testing of Phase 1 investigational drugs must be completed to evaluate quality attributes including identity, strength, potency, and purity. Celerion’s comprehensive approach includes a fully integrated pharmacy and analytical laboratory facility. Celerion’s on-site pharmacy allows for “just in time” flexible formulation, saving clients time and money. Leveraging state-of-the-art equipment and expert analysis, Celerion refines pharmaceutical dosage formulations efficiently and effectively. This enables seamless compound analysis and testing, optimizing efficiency, speed, and control throughout development and testing phases. “Offering comprehensive analysis and testing capabilities under one roof provides sponsors with rapid, reliable solutions that meet regulatory requirements without compromising quality,” said Chad Briscoe , Ph.D., Executive Vice President, Global Bioanalytical Sciences. “In the face of evolving regulations, timely access to accurate sterility test results is paramount,” said Phil Bach , Executive Vice President, Global Clinical Research. “Our in-house capabilities for sterility testing and analysis allow us to accelerate this critical step within our controlled environment, providing sponsors with unparalleled speed and development schedule oversight.” About Celerion Celerion , a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path. For over fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamic studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism, and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. In addition, Celerion offers data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends, and people in need around the world. For more information, please visit www.celerion.com .

LINCOLN, Neb--(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 and diagnostic services into its comprehensive suite of bioanalytical solutions. Celerion’s clinical laboratories, including their Lincoln site, have been CLIA-certified and CAP-accredited for over 25 years, which helped facilitate the CLIA certification of the laboratory. The CLIA certification is a testament to Celerion’s adherence to the highest standards of laboratory quality and competence. It enables Celerion to conduct non-waived testing on human specimens, a critical component in the health assessment, diagnosis, prevention, and treatment of diseases. This certification is particularly crucial as it allows Celerion to perform these vital tests prior to the full accreditation inspection by a CMS-approved agency, ensuring continuous advancement in patient care and clinical research. With this certification, Celerion’s bioanalytical laboratory is now able to conduct lab-developed tests in specialized areas such as diagnostic immunology. These tests, recognized for their “high complexity” and stringent CLIA oversight, include but are not limited to ADA (anti-drug antibodies), NAb (neutralizing antibodies), and a wide array of biomarker assays. These assays are instrumental in determining patient inclusion and exclusion criteria for clinical trial enrollment, thereby enhancing the precision and efficacy of clinical studies. Moreover, the CLIA certification allows Celerion to engage in studies that require the reporting of patient-specific results. This capability is crucial for tailoring patient care and treatment, such as adjusting individual dosing based on specific data, distinct from the standard dosing for the general study population. This approach not only underscores the personalized aspect of patient care, but also significantly contributes to the optimization of therapeutic strategies and outcomes. Celerion’s Executive Vice President, Global Bioanalytical Sciences, Dr. Chad Briscoe, stated, “Achieving CLIA certification for bioanalytical assays is not just a milestone for Celerion, but a leap forward for the entire field of bioanalysis and clinical research. It underscores our unwavering commitment to quality, precision, and innovation. With this certification, we are poised to deliver enhanced value to our clients and contribute more profoundly to the advancement of healthcare and patient treatment options.” About Celerion Celerion, a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path. For over fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamic studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism, and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. In addition, Celerion offers data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends, and people in need around the world. For more information, please visit .

LINCOLN, Neb.--( 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 in the annual Contract Research Quality Benchmarking online survey conducted by Industry Standard Research . Celerion received a CRO Leadership Award in all five categories, including capabilities, compatibility, expertise, quality, and reliability. “ We are honored to receive this prestigious recognition and would like to extend our sincere appreciation to our clients for their trust and support,” says Celerion CEO Susan Thornton , Ph.D. “ This recognition is a reflection of our continued focus on innovation, quality, and customer satisfaction. We believe that our unwavering commitment to these principles is the foundation of our success and sets us apart from our competitors,” she added. About Celerion Celerion , a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path. For over fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamic studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. In addition, Celerion offers data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends, and people in need around the world. For more information, please visit www.celerion.com .