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.
New Blog: "Ask the IRB Experts"
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53:35Our experts teamed-up to take on your safety questions and provide you with tactics and strategies to overcome the biggest challenges plaguing your studies today.
1:11Custom-built to streamline the adjudication process, the AIMS platform allows for enhanced endpoint adjudication capabilities.
From cardiovascular adverse events to complex dosing regimens, oncology trials present unique safety-related considerations.
Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk
This publication discusses emerging cardio-oncology nuances and the latest regulatory thinking on ways to manage risks.
Steven Beales and Joe O’Rourke, vice president, business development talk through some of the difficulties Sponsors face when it comes to safety letter distribution, and how to overcome them.
13:58What’s the role of expert committees today? What’s happening on the regulatory side? Dr. Seltzer, Chief Scientific Officer of WCG Clinical, shared his insights on expert committees during a recent...
Due to evolving practices and increased regulatory attention on expert committee operations, sponsors are turning more to independent providers with experience in managing expert committees.
Dr. Seltzer, president and founder of ACI Clinical, and chief scientific officer of WCG Clinical, shared his insights on expert committees during a recent conversation with Bill Stedman.
54:41Learn how a large, global pharmaceutical company saved millions of dollars by optimizing their safety reporting process.