Adequately trained monitors/clinical research associates (CRAs) “will be prepared for just about anything” an increasingly complex clinical trial landscape is liable to throw at them, says Maggie Potrikus, BSN, CCRC, MBA, a quality assurance and compliance manager with Concentrics Research, a contract research organization (CRO), and former contracted CRA to Roche Diagnostics. On the other […]
A new guidance from the U.S. Food and Drug Administration (FDA) provides the agency’s latest thinking on how it defines the types of changes to approved risk evaluation and mitigation strategies (REMS) for the monitoring of medications with a high potential for serious adverse effects, how application holders should submit changes to an approved REMS, […]
Eva Mozes Kor, a survivor of Nazi experiments conducted on twins by Dr. Josef Mengele during World War II and a memorable two-time speaker on the importance of medical research ethics at ACRP annual meetings, passed away last week peacefully at the age of 85 during a trip to the concentration camp from which she […]
Atlantic Research Group (ARG), IACT Health, and Veeva Systems will discuss the industry perspective on data sharing and collaboration in clinical research, the use of metrics to optimize performance, and strategies that reduce information overload and simplify how sites, sponsors, and CROs work together throughout the clinical trial process.
RegisterThis session will cover identifying, assessing, and reporting adverse events (AEs) for medical device studies at the site level.
RegisterThis presentation will focus on lessons learned from a recent observational study of 6 clinical research sites over the course of three years.
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