A “clear inconsistency” in site monitoring process outcomes during clinical trials is placing an “unsustainable” strain on the demand for and management of clinical research associates (CRAs) today—and it’s only […]
If the term “digital twin” conjures up scary images of Frankenstein-like human experimentation or “Westworld”-style human-replicating androids run amok, don’t worry. It’s actually a scientifically sound concept on the verge […]
“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 […]