With increased attention on response to ICH E6 (R2) guidance and on achieving higher levels of transparency and speed, many pharmaceutical companies have begun to implement new CRO oversight practices and mechanisms. This demo presents the results of a recent study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) that benchmarks CRO oversight practices and their impact and effectiveness.
Ken Getz of Tufts CSDD discusses the summary results of the study and their implications. Specific areas covered include:
- Types of CRO oversight models used for the variety of outsourcing approaches utilized
- Oversight challenges in transparency, risk, and compliance areas
- Industry experience with different oversight models and their reported impact and effectiveness
- Performance metrics gathered to measure oversight effectiveness
- Insights into new approaches being implemented and planned to improve oversight effectiveness
Also discussed are industry trends and ways to overcome Oversight challenges including transparency, risk and compliance.