Data Coordinating Center

The Data Coordinating Center (DCC) service areas include data management and statistical support for first-in-human through phase IV studies for both medical devices and investigational drugs. CRF’s strong capabilities within these service areas contribute to the quality data capture and analysis critical to successful regulatory approval.

Data Management

Comprised of industry experts with experience working on high-profile trials, our dedicated team offers comprehensive data management services including eCRF development, database design and build, query management and data verification. The DCC offers a customizable approach to data monitoring and database builds across a variety of platforms including MERGE, RAVE, eCaselink, ClinPlus, and iMednet. Utilizing an efficient and proactive approach, the CTC’s data managers monitor study data for errors and trends to facilitate the highest level of quality data.

Biostatistics and Programming

Our expert statistics team offers innovative clinical trial design expertise and biostatistical support on high-profile industry and academic sponsored trials and projects. Highly knowledgeable in the regulatory landscape, we navigate the intricacies of clinical trial design by performing sample size calculations and adaptive design. Our team applies advanced biostatistical and programming techniques to produce endpoint analyses for abstracts, presentations and publications, which are completed in collaboration with our world-class physician faculty. Additionally, we are experienced in trial safety and provide independent biostatistical services for DSMB activities.

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