Advanced Clinical Trials and Clinical Research

eSource & EDC Systems

Electronic Source (eSource) and Electronic Data Capture (EDC) systems are at the heart of efficient, high-quality data collection in clinical research. This session explores the design, implementation, and validation of eSource and EDC platforms, emphasizing regulatory guidance from FDA, EMA, and ICH GCP. Topics include system interoperability, real-time data entry, remote access, and user-friendly interfaces that support decentralized and hybrid trial models. Attendees will learn how to select the right technology stack, ensure 21 CFR Part 11 compliance, and mitigate common data entry and reconciliation issues. The session highlights best practices for training, vendor oversight, and audit readiness. Case studies will show how eSource integration with wearables, ePROs, and lab systems improves data accuracy, reduces lag time, and enhances overall trial efficiency. Whether upgrading systems or launching new trials, this session offers a roadmap for optimizing digital data collection infrastructure.