From Risk-Based Monitoring to Risk-Based Validation

Prioritizing Resources for System Validation and Data Integrity in Life Sciences

In 2012, clinical operations teams faced a stark reality: 30% of trial budgets were routinely consumed by site monitoring. It was demonstrated that a prime on-site activity, Source Document Verification (SDV), yielded minimal improvements in data quality. Clinical Data Managers (CDMs) bore the burden of ensuring data integrity, while Clinical Research A…