Clinical Pharmacology Services

Clinical Pharmacology Sciences at Celerion bridges the gap between medical practice and laboratory science by assessing the safety of drug products to maximize drug effects and minimize side effects.

The scientists at Celerion design efficient, scientifically sound clinical studies; analyze and interpret data from these studies; and use the knowledge obtained to design the next study in the drug-development cycle. The scientists provide the following:

• Estimate optimal dosing for human trials based on animal or human results
• Design early clinical research studies and write protocols to evaluate safety and pharmacokinetics/ pharmacodynamics (PK/PD)
• Analyze and interpret data from clinical trials
• Communicate results from human trials for regulatory filings

Celerion has one of the most experienced Clinical Pharmacology Sciences teams in the industry, with over 120 staff operating across six global locations in North America and Europe and nearly 40 years of experience. The team produces more than 200 clinical study reports annual and has developed over 4,000 protocols. Clinical Pharmacology Sciences offers expertise in the following areas:

• Modeling and simulation
• Study design and protocol development
• Data management
• Biostatistics
• Pharmacokinetics / pharmacodynamics (PK/PD)
• Medical writing and reporting

Celerion offers a fully integrated SAS® Drug Development platform providing a centralized system for managing, analyzing, reporting and reviewing clinical research information.
Benefits include:

• Reliability: Improved data integrity through seamless integration with complete traceability
• Consistency: A standardized approach to data collection from multiple sources, uploaded and integrated into a centralized repository to provide a secure and consistent data structure
• Speed: Faster access to data for all clients and immediate access for those with in-house SAS® Drug Development enabling faster go/no-go decisions by up to four to six weeks of the drug’s overall development timeline
• Submission-ready Data: Full compliance with regulatory requirements including 21 CFR Part 11, good industry practice, CDISC and CDASH standards enables submission-ready data and potentially faster review by FDA and other regulatory agencies

Celerion’s streamlined data-flow process maintains consistency with industry-leading CDISC standards from data collection through data submission.

Data capture

ClinQuick®, Celerion’s proprietary electronic data-acquisition system, provides consistency of clinical operations cross all sites, ensuring accurate, high-quality data and reducing time to database lock.

Data output

Celerion utilizes in-house CDASH-compliant data-acquisition SAS® database format and associated electronic PDF format CRFs to set initial expectations, fully scope the project and standardize accepted data formats, resulting in time savings on the back-end. The submission database content/structure is usable throughout the drug-development lifecycle of a compound, reducing costs and eliminating rework.

Data migration

Celerion expedites the conversion of clinical study data from CDASH to CDISC while maintaining compliance with FDA and other regulatory agencies. Services include biostatistics – detailed statistical analysis plans, and tables, figures and listings (TFLs) in addition to PK/PD analysis and interpretation.

Data submission

Celerion is one of the leading CROs for complete data reporting, thereby saving sponsors’ time and money on overall drug-development timelines. The structure of the ICH E3 Clinical Study Report is compliant with the eCTD and is delivered as a fully electronic PDF format standard deliverable (vs. paper) to assist clients in their submission process. The addition of SAS® Drug Development to Celerion’s services portfolio enables the delivery of submission-ready data in an eCTD-compliant format while expediting delivery of items 11 and 12.