PRA Health Sciences (PRA) experts have significant experience providing end-to-end risk management services. Our integrated global teams identify innovative solutions to satisfy key regulatory requirements and provide effective strategies to ensure the benefit-risk profile of the product remains favorable for patients.
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Adjudication can be a tool to improve the confidence of trial data, although it is essential to have a clear and defined process. Historically,…

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In this white paper, best practices are described as well as required Sponsor/Local Representative agreement areas. It is important that major…