“The best way to survive an FDA inspection is to always be prepared for one,” advises Michelle Anantha, MSPAS, PA-C, RAC (US), with the U.S. Food and Drug Administration’s (FDA’s) […]
Leading U.S. Food and Drug Administration (FDA) officials hailed clinical study investigators as some of the unsung heroes of the clinical trial ecosystem during an agency training course last week […]
“My prediction is that clinical trials in 10 years’ time will be very hard for us to recognize,” Leonard Sacks, MD, associate director for clinical methodology in the Office of […]
The quest for greater levels of patient engagement in clinical trials is surfacing as a clearly stated driver behind more and more new research partnerships and services being announced in […]
The seemingly inevitable rise of hybrid or outright virtual clinical trials with minimal or no patient site visits presents clinical trial professionals with a classic case of threat and opportunity, […]