Course Description

The stipulation of taking a more proactive approach to managing risk in clinical trials is a major component of ICH GCP E6. As outsourcing in clinical development continues to grow, so do the challenges of ensuring quality outcomes. In this web seminar, recommendations for sponsor oversight practices are discussed, as well as tools and best practices for managing vendor relationships. Managing a vendor vs. micro-managing a vendor will also be discussed.

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Learning Objectives

• Identify key approaches to planning and preparing to outsource while managing clinical trial risk
• Identify key components for formal study of vendor performance management
• Identify adequate oversight SOPs and other practices
• Employ end of project analysis to pave the way for improvement in future relationships

Who Should Attend

• Sponsors
• CROs/Vendors
• Those that choose, manage, or evaluate external service providers

Instructor

Treena Jackson, M.S., M.A., C.Q.A., R.A.C., C.S.S.G.B.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.