CRO & Vendor Oversight
Keep every CRO and vendor accountable to your program, with oversight you can demonstrate.
The challenge
Status reports can say a study is on track while enrollment, data and documentation suggest otherwise. Under ICH GCP, the sponsor remains responsible for the trial-related duties it delegates, so oversight cannot be outsourced with the work.
Scope of support
- Support for CRO and vendor selection: RFP, bid review and capability assessment
- Oversight plan design: KPIs, reporting requirements and escalation paths
- Review of CRO deliverables, metrics and invoices against contract scope
- Joint governance meetings and issue resolution
- Change order and scope management support
Key deliverables
- Vendor oversight plan with KPIs and thresholds
- Bid comparison and selection recommendation
- Periodic oversight reports with findings and actions
- Documented oversight evidence for the trial master file
Expected operational benefits
- Performance issues identified earlier
- Clear expectations for every partner
- Oversight documentation that supports inspection readiness