eSource vs. EDC: Reimagining Your Clinical Trials

eSource, as defined by the FDA, refers to clinical trial data initially recorded in electronic format and includes data from eCOAs, medical devices, LIMS, and eICFs. Traditionally, clinical research sites have captured source data manually or in non-sponsor systems, necessitating transcription into Electronic Data Capture (EDC) systems. However, this process introduces inefficiencies and data quality risks. Unlike EHR systems—which are ill-suited for study-specific protocol requirements—dedicated eSource platforms are optimized for trial workflows.

Site-based eSource is a rapidly growing category, with platforms like CRIO enabling sites to collect protocol-specific source data directly and electronically. CRIO estimates 35% of U.S. sites now use eSource, especially among high-performing networks. Although FDA guidance allows direct EDC entry, traditional EDC systems are not designed to support comprehensive, site-centric data workflows. To bridge this gap, CRIO offers a Central eSource solution, enabling sponsors to standardize source templates and integrate seamlessly with EDC systems. This approach reduces site burden, eliminates double data entry, minimizes queries, and enhances remote monitoring.