NIH RAC Changes

Tue, Aug 21st 2018

The changes to the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) protocol review and reporting structure, which were reflected in changes to the Federal Register on August 17th, 2018, will affect gene and cell therapy Sponsors in these three significant ways.

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How to prevent clinical trial protocol deviations

When protocols are not followed, it can create serious issues that slow the study down or significantly increase costs.  These best practices can help sponsors and CROs work together seamlessly to prevent and alleviate protocol deviations in their clinical studies keeping development on time and within budget.
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