CRO Oversight: Regulatory Submission Point of View
Aakar Shah and Tracy Sherman
As regulatory agencies become more stringent in accepting submissions and as Contract Research Organizations (CROs) work share increases in the Pharmaceutical industry, need for smart oversight of CROs become critical for a sponsor’s success. Regardless of the extent of CRO involvement, at the end of a day, the sponsor is responsible for submission compliance to regulatory agencies. Due to the lack of CRO oversight, delay in submission even by one day could cause loss of millions of dollars and more importantly patient’s lives can be affected. This paper will discuss various areas that are related to CRO oversight for successful regulatory submissions such as stakeholder management techniques, sponsor communication, use of sponsor metadata, contract update and sponsor’s submission focused review.
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