Presenter: Pam Dellea-Giltner
FDA Regulations and the updated ICH E6R2 addendum note more expansive requirements for vendor oversight including quality systems and risk management awareness. This does not mean after signing the contract, your team finds out they are not compatible with the vendor or the vendor cannot provide the full services needed for the study. The sponsor needs to have internal analyses and planning processes up front to define requirements for choosing the right vendor.
Sponsors are outsourcing more clinical research processes, and they need to have both the team and processes in place to bring on vendors and manage them to be compliant and ensure a cohesive team approach. Sponsors are now even more responsible for vendor oversight and performance, but how is this accomplished?
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