The final webinar in the series will evaluate the industry value chain for the exchange of digital nonclinical data which is undergoing a significant change as a result of the FDA’s guidance mandating SEND submissions. In this session, we will discuss and debate several challenges regarding sponsor-CRO data exchange interactions. We will offer practical approaches including the use of model management and study data definition specifications. We will discuss how these processes can be setup and calibrated by CROs and their sponsors to achieve frictionless flow of reliable and compliant SEND datasets in advance of the timelines to comply with the FDA’s mandate.
We would like to hear back from you about our webinars. What topics would you like to see more of? Please let us know by sending your suggestions to John Rivara at