The CRO Oversight Plan is a guideline for the ClinOps team to ensure the vendor’s adherence to the Scope of Work (SOW), study-specific plans, processes, procedures, and GCP guidelines. The development of a Quality Agreement and Oversight Plan documents the frequency and process for:
- KPI Definition
- KPI Monitoring
- Issue Management
During this webinar we covered a case study of a leading pharma company who automated their quality agreement and CRO oversight plan to meet imminent ICH E6 (R2) requirements.