In this issue of the journal, Jonathan Seltzer presents an important review of the rationale and best practices for event adjudication in medical device clinical trials. The concepts presented in this work are well aligned with Food and Drug Administration's (FDA's) expectations for an adjudication process that enhances clinical study quality.
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In a recent webinar, Steven Beales, Senior VP, Scientific and Regulatory at WCG, facilitated a conversation with FDA leaders, discussing overreporting SUSARs and the impact on patient safety.
16 industry experts share shifts and trends that will inform clinical research in 2020 and beyond.