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Archive: Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools
Partnerships with clinical vendors are critical to the success of the trial. Sponsors, as well as vendors who hire other vendors, require both performance and quality oversight. Whether your organization hires different vendors per protocol/program, or you’re in a preferred provider partnership model, you always encounter potential risks. This web seminar will provide a systematic, structured, proactive approach to risk management in outsourced clinical trials. We will discuss the internal and external factors for the organization to identify, assess, manage, and continuously monitor throughout the life of a project and/or partnership (e.g., protocol, investigational plan, regions, sites, vendors, and resources).
- Describe the attributes of a risk management framework for use in outsourced clinical trials
- Identify sponsor’s oversight requirements included in ICH GCP E6 R2
- Identify potential risk areas with outsourced trials
Who Should Attend
- Sponsor Personnel that choose, manage, or evaluate external service providers
- Vendor/CRO Personnel responsible for trial oversight
- Vendor Personnel that choose, manage, or evaluate other vendor partners
Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.