“invivodata was able to deliver us the real-time data that we needed to develop an unbiased view into our patients’ pain experiences. This kind of data cannot be collected with paper diaries.”
Dr. Michael Gendreau
Chief Medical Officer, Cypress Bioscience
In this industry profile, Dr. Jean Paty, Chief Scientist and Regulatory Advisor of PRO Consulting discusses the FDA's draft guidance on PROs in clinical research and the importance of measuring patient-reported endpoints from a regulatory perspective, including the process for developing an endpoint model to meet regulatory expectations.
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