From Data Capture to Decision: Why EDC Should Drive Your Clinical Oversight Operating Model
Many organizations use both Electronic Data Capture (EDC) and Clinical Trial Management System (CTMS) platforms but still struggle to demonstrate how emerging data quality issues are identified, addressed, and resolved. Traditionally, these systems operate in parallel, creating an oversight gap between data management activities and clinical operations.
This article explores how ICH E6(R3) is shifting expectations toward risk-proportionate, data-informed oversight. It examines a more integrated operating model in which EDC provides operational signals while CTMS serves as the system of record for oversight decisions, actions, and supporting evidence. This approach helps sponsors and CROs strengthen trial oversight and improve accountability.
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