The transition to ICH E6(R3) makes your current oversight model for Phase 4 and RWE a liability. When data is scattered across recruitment portals, eConsent tools, and EDC systems, “centralized monitoring” usually results in manual spreadsheet reconciliation and late-stage panic.
In this spotlight, Lisa Charlton, Connor Ladley-Fredeen, and Maximiliano Senestrari demonstrate how to build a functional oversight framework. We focus on using Castor’s open API to pull recruitment, consent, and enrollment data into one view. You will see how to use AI-driven signals to catch data timeliness issues and consent version errors before they become audit findings.
The session covers the practical application of risk-based quality management in studies where site engagement fluctuates. We will show you how to maintain a continuous, inspection-ready audit trail using your own data architecture.
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