Don’t Let Fear Stifle Innovation

As an accomplished motivational speaker, it would be pretty easy for classical violinist Kai Kight to stick with the same presentation over and over. However, that’s not how he rolls. “I’m nervous before every talk because I try new things all the time,” he says. Something’s obviously working: He was just named one of the […]

Steer Clear of Trouble with Strong Monitoring Visit Report, Expert Advises

Well-written monitoring visit reports will keep you out of trouble, says Kathryn Kimmel, CCRC, CCRA, a senior clinical research associate with PRA Health Sciences. “It’s the first thing site auditors look at before they visit for a sponsor inspection,” she says. It gives them a framework for what to expect when they walk in the […]

FDA Keeping Eye on Online Drug, Device Benefit Promises

The U.S. Food and Drug Administration (FDA) understands you can’t control absolutely everything posted about your drug or device as part of your effort to solicit new clinical trial subjects, but you’d better keep an eye on promises made regarding how much your product can benefit people. That’s the warning from Mitchell Parish, JD, RAC, […]

FDA: Risk-Based Monitoring Remains Fuzzy Concept in Clinical Trials Industry

Risk-based monitoring (RBM) has become a confusing buzzword that too often means different things to different people. That’s a potentially dangerous situation, says David Burrow, acting deputy director of the Office of Compliance for the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER). “RBM should be one part of a larger […]