- Compliance with ICH-GCP E6 (R2)
- Integrated Shared Governance
In compliance with the ICH-GCP E6 (R2) guideline, we jointly develop and implement an active and efficient CRO management/vendor management plan for conducting your clinical trial. Optimized interaction between sponsors, CROs and vendors by mastering different corporate cultures, expectations and efforts will advance your company to the next development stage.
What we can do for you
Risk-based CRO/vendor management plan
- Definition of risks
- Implementation of risk mitigation strategies and early warning systems
Active performance evaluation
- Active monitoring and performance evaluation of CRO and vendors using Key Performance Indicators (KPI)
- Implementation of a shared governance model
- Agreement on expectations to optimize the partnership
- Development of a joint vision for a successful study performance
Our expertise, your benefits
We have successfully implemented CRO/vendor management concepts and tools in close cooperation with our customers. You benefit from our expertise from working with sponsors and CROs/vendors and our deep understanding of processes and workflows.