Celerion's streamlined data-flow process maintains consistency with industry-leading CDISC standards from data collection through data submission.
ClinQuick®, our proprietary electronic data-acquisition system, provides consistency of clinical operations across our sites, ensuring accurate, high-quality data and reducing time to database lock.
Celerion utilizes our 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.
Celerion expedites the conversion of clinical study data from CDASH to CDISC while maintaining compliance with FDA and other regulatory agencies. Our extensive services include biostatistics – detailed statistical analysis plans, and tables, figures and listings (TFLs) in addition to PK/PD analysis and interpretation.
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 our services portfolio enables Celerion to deliver submission-ready data in an eCTD-compliant format while expediting delivery of items 11 and 12.