Celerion’s streamlined data-flow process provides high-quality data quickly by utilizing Omnicomm TrialMaster® and industry-leading CDISC standards to capture data at the site and ultimately deliver complete data in submission-ready format.
Celerion utilizes Omnicomm TrialMaster® as the preferred electronic data capture (EDC) system, for data capture on multi-site studies, ensuring accurate, high-quality data and reducing time to database lock.
Celerion’s experienced Data Managers oversee the entire management of the data from beginning to end, including working with the client, internal and external sites and monitors to review, trend, query and clean data on an ongoing basis. Our internal processes combined with technology allow us to provide transparency in the data management process as well as provide ongoing feedback on entry and monitoring.
In designing electronic CRFs that meet the needs of the study and the database, to facilitate CDISC-compliant deliverables, Celerion is able to set initial expectations, fully scope the program 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 delivery of clinical study data into SDTM and ADaM format 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.