Protocol violations and faulty record-keeping habits continue to be among the most common problems uncovered by U.S. Food and Drug Administration (FDA) inspectors, says David Burrow, PharmD, JD, acting director of the Office of Scientific Investigations within the Office of Compliance for the FDA’s Center for Drug Evaluation and Research. Burrow’s tip? Remember that “quality […]
Potential clinical trial subjects will be far more likely to participate if they are convinced doing so will benefit their overall health, says Jennifer Byrne, CEO of PMG Research. However, there must be action behind the words explaining trial-related concepts, she stresses. “Broadening the total value proposition of clinical research” needs to go beyond buzzwords, […]
“Any risk management plan is going to be important, but even more so now because we have the ICH E6 revision [from the International Council for Harmonization] that explicitly calls for quality management” in the conduct of clinical trials, notes Deborah Rosenbaum, a clinical research consultant and trainer with Sarrison Clinical Research, llc. The ICH […]
While the demands on clinical research professionals to deliver high-quality study data more quickly and efficiently have arguably never been greater, industry continues to shy away from adapting technologies and new best practices that could help lighten the load, experts say. “There is a lot of work to be done to manage the disparate pieces” […]
