Safety Data Reconciliation (EDC vs. PV): Blueprint, Execution, and Audit-Proof Controls
Safety Data Reconciliation (EDC vs. PV): Blueprint, Execution, and Audit-Proof Controls EDC–PV Safety Reconciliation: Designing Reliable Processes That Regulators Recognize Why EDC↔PV Reconciliation Exists—and What Regulators Expect to See Safety data reconciliation is the systematic comparison of safety facts recorded in the clinical database (EDC) against the pharmacovigilance (PV) safety system (e.g., Argus/ARISg). Its purpose…