Celerion Differentiators

Celerion's combination of experienced people, scientific excellence and state-of-the-art facilities strongly positions us as an industry leader in the conduct of early clinical research and bioanalytical studies.

Experience and expertise

• Leadership with extensive depth and breadth of experience in drug development
• Clinical study design, execution and analysis that leverages the scientific experience of Celerion’s staff
• Over 25 years’ experience in conducting over 300 First-in-Human studies to provide confidence that the inherent risks of early clinical research are clearly understood and well managed
• One of the largest Clinical Pharmacology Sciences teams in the industry, evaluating over 300 protocols per year and producing over 200 reports annually
• Drug Development consultants that help clients establish product value through design and execution of an integrated program of studies focusing on demonstrating early evidence of drug safety and effect
• Regulatory strategy and technical support for INDs and CTAs in North America and Europe

Scientific excellence that leverages innovative technologies

• Market leader in early cardiac studies – first CRO with a Hybrid Phase I/ECG Core lab utilizing Bluetooth Holter monitors and automated ECG review that benefit clients with faster access to data, lower costs and higher quality data
• Data on demand using the SAS® Drug Development platform. Celerion is the first global CRO to offer a fully integrated SAS® Drug Development platform to provide a centralized system for managing, analyzing, reporting and reviewing clinical research information
• Deployment of electronic lab notebooks in Celerion’s global bioanalytical facilities drives efficiency and fast turnaround of PK information for early clinical research decisions
• Utilization of radioactive microtracers in early clinical research in regulated clinic facilities enables understanding pharmacokinetic and metabolism questions early; full capabilities for performing comprehensive ADME programs
• Addition of a USP <797> 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.

Strategically located state-of-the-art facilities

• Global network includes sites in Lincoln, Nebraska; Neptune, New Jersey; Phoenix, Arizona; Belfast, Northern Ireland and Zurich, Switzerland; as well as operations in Richmond, Virginia and Montreal, Canada
• Large global clinic presence operating under a common recruiting database and SOPs to enable flexible and effective subject enrollment
• Purpose-built facilities with co-located pharmacies, clinical laboratories, clinical conduct areas, bioanalytical laboratories, and clinical pharmacology sciences to expedite drug development