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Clinical & Medical Affairs

Clinical Trial Vendor Oversight and Governance - WHITEPAPER


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Outsourcing of clinical trials is undertaken by pharmaceutical companies for a number of reasons including reduction of costs of conducting clinical trials, reducing wastage by engaging a vendor with manpower and expertise in the area of interest for the sponsor, and achieving reduced cycle times of introducing a new product in the market. While these reasons form the basis of outsourcing, the sponsor treads a thin line distinguishing between micromanaging each and every step and effective oversight in the implementation of the clinical trial.

This whitepaper explores:

  • Vector selection: procurement strategies and contract design

  • Regulatory requirements with ICH GCP guidelines

  • Vendor responsibilities for data sharing with the sponsors

  • Quality agreements and monitoring

  • Risk minimization

  • Overseeing technology vendors

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ABOUT THE AUTHOR: Poonam Balani has a PhD in biomedical sciences from the University of Muenster, Germany. She has 14 years of experience in medical and academic writing and has worked as a researcher at the University of Tennessee Health Science Center, USA and the Institute for Bioengineering and Nanotechnology, Singapore.

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