Drug developers and global regulators are rapidly expanding the use of real-world evidence (RWE) to design, test, and review rare disease treatments, but knowledge gaps on the part of payers regarding the validity and value of RWE are limiting patients’ access to such breakthroughs in ways that should be tackled, according to a new […]
To the uninitiated, the term “advanced analytics” might sound a bit dry, but it holds exciting promise to make clinical trials far more efficient and deliver vital drugs and treatments to patients more quickly and safely, say a quartet of thought leaders with hands-on experience leveraging its benefits. “Advanced analytics can enable faster detection of […]
A new guidance from the U.S. Food and Drug Administration (FDA) offers the agency’s latest thinking on how industry should design, run, and handle data reporting when leveraging adaptive clinical trials. The final “Adaptive Designs for Clinical Trials of Drugs and Biologics” guidance is largely unchanged from its 2018 draft predecessor. The guidance also […]
This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue for regulatory submissions.
RegisterWe invite all CRCs, CRAs, Project Managers, Regulatory Liaisons, and other study personnel to join this webinar for a review of our responsibilities and a discussion of these relationship. Feedback from high performing sites on strategies for collaboration and relationship building will be shared and open forum for discussion provided.
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