Human Factor Looms as Significant Hurdle to Expanding Virtual Trials

As an industry professional, you may be fired up about the wonders promised by virtual trials. You’re jazzed by the prospect of expanding care to underserved patient populations and remote parts of the country. You can’t wait to get innovative new products to market more safely and efficiently. Great. Now it’s time to convince the […]

ACRES Partners with ACRP to Advance Professionalism of Clinical Trial Workforce

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 a quality-based global standard for clinical research sites. It realizes the six-year effort of the ACRES Site Accreditation and Standards Initiative (SASI), carried out by […]

Direct-to-Participant Trials Struggle with Definitions

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 trials,’” said Steve Cummings, Director and SF Coordinating Center Professor of Medicine and Epidemiology at UC San Francisco. No, it’s not that he doesn’t believe […]

FDA Hits Sponsors with Higher Drug Development Fees

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 price increases effective October 1. The agency’s FY 2020 fees under the Prescription Drug User Fee Act (PDUFA) are climbing almost 15%.  New drug and […]