Tuesday, July 06, 2010 7:37 PM
FDA Inspection Trends
By Jill Cernohous, Senior Principal Advisor Clinical Affairs, RCRI Inc.
The landscape of today’s clinical trials is ever changing, posing greater challenges for sponsors, investigators and FDA alike. Challenges include increased complexity, novel therapies, large multi-site trials, inclusion of vulnerable patients, trials conducted outside of the United States, and outsourcing of various trial related responsibilities. In response to these complexities, FDA is implementing several new initiatives to maintain better oversight, and sponsors and investigators will need to be more vigilant throughout all phases of a clinical trial in order to achieve success.
One such initiative recently implemented by FDA is to conduct routine inspections of contract research organizations (CROs). Realizing the integral role CROs play with more sponsors outsourcing critical tasks or the entire trial, FDA is increasing their oversight of CROs. A CRO that assumes any obligation of the sponsor will be held to the same regulatory actions as a sponsor for failure to comply with applicable regulatory requirements. Another FDA initiative is the I more...
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