The Alliance for Clinical Research Excellence and Safety (ACRES) just launched what it calls a road-tested program to accredit clinical research sites worldwide. The accreditation process is grounded in […]
Shakespeare’s Juliet famously asked what’s in a name, but for at least one thought leader in the clinical trial space, names do matter. A lot. “Please don’t call them ‘virtual […]
Consumers probably aren’t the only ones complaining about the rising cost of prescription drugs—not after the U.S. Food and Drug Administration (FDA) just socked drug study sponsors with hefty […]
The U.S. Food and Drug Administration (FDA) just issued a call to industry and other interested parties to weigh in on an important draft guidance, “E8(R1) General Considerations for Clinical Studies.”
If you have the pleasure of knowing me in the professional world, or perhaps sitting through one of my lectures, you’re all too familiar with what I have to say […]