Sandra "SAM" Sather
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment. This balance requires a risk-based approach at the system and project level. Whether sponsors adapt a best of the breed vendors outsourcing or strategic partnership with few CRO/Vendors for their projects, ultimate responsibility belongs to sponsor, both in the eyes of regulators and patients. Therefore, it is important to have solid oversight and risk management in place to ensure this responsibility is met effectively. In addition, this should not lead to more micro-management as vendors are paid to do the tasks, inturn sponsors should not spend additional resources or time as this defeats the purpose of engaging CRO/Vendors.
The development of an appropriate oversight strategy is critical which not only focuses on KPIs and metrics but will also highlight key risk areas or critical success factors that one wants to measure through the oversight process. This webinar will focus on CRO/Vendor oversight and also how technology can be leveraged effectively for oversight/governance purpose.
- Importance of CRO/Vendor oversight in clinical trial management.
- Identify the ways to integrate a risk-based approaches to CRO/Vendor oversight.
- Developing a CRO/Vendor oversight plan with appropriate KPIs/metrics to be measured.
- Use of tools and technology for accurate and timely reporting.