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 webinar 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.
Join Ken Getz of Tufts CSDD as he discusses 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
Ken Getz, Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine
Kenneth A. Getz is the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine where he directs research programs on drug development management strategy and practice including protocol design and execution; outsourcing; investigative site management; and patient recruitment and retention. He is the chair of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. Ken is also the founder of CenterWatch, a leading publisher in the clinical trials industry.
Julie Peacock, Clinical Intelligence Expert, Comprehend
Closely aligned with customers and the sales organization, Julie focuses on enabling prospects and customers on Comprehend’s Clinical Intelligence solutions. She manages go to market strategy, sales enablement, and product marketing.
Prior to Comprehend, Julie spent 18 years at Oracle Corporation in the enterprise application space where she managed strategy, field enablement and launch activities for a series of BtoB solutions. Julie holds a bachelor’s degree in Marketing from Auburn University.