The challenge
Data quality issues were being detected at monthly review, by which point corrective action at sites was slow and expensive.
What we did
- 01Unified EDC, central lab and eCOA streams into one review model
- 02Trained anomaly detection on historical study deviations
- 03Deployed the Study Conduct Agent with explicit escalation rules
- 04Instrumented every escalation for false-positive review
Results
- Earlier detection
- 11 days
- Query volume
- -38%
- Monitoring cost
- -21%
Client: Mid-cap clinical sponsor