FDA Inspectors Becoming More Specialized

Next time you have an encounter with an FDA inspector, don't be surprised if they really know their stuff. In a policy shift, the agency is working to make its inspectors more specialized. It's becoming less likely that your inspector "will come to your facility and then go to a factory the following week," Chavon […]

Getz: CROs Challenged by Increasingly Demanding Protocols, Miscommunication

Total data points collected in a typical Phase III Protocol have nearly doubled since 2005, Ken Getz, founder and owner of CenterWatch, told attendees at ACRP's 2016 Meeting and Expo today. Between 2001 and 2005, sponsors sought 494,236 data points in a typical Phase III Protocol.  Between 2011 and 2015, CROs had to contend with […]

FDA Shares Nine Secrets to Effective 483 Response

FDA's Office of Scientific Investigations (OSI) conducted 430 clinical investigator-related inspections in 2015, and while just six resulted in 483s (compared to 16 in 2014), it's not something industry should take lightly. In fact, while responses are optional, the wise strategy is to respond as soon as possible, advised David Burrow, Acting Deputy Director at […]

Keynote Speaker Kai Kight Inspires ACRP Members to Dream Big

Kai Kight knew something was wrong the moment he saw his mother's face. She'd been crying. She wouldn't look him in the eye. Finally, she told him the terrible news: She had breast cancer. "We talked into the night," the virtuoso violinist told a rapt audience at the ACRP 2016 Meeting & Expo in Atlanta […]

Have You Incorporated the Core Competency Domains into Your ePortfolio?

In a wide-ranging ACRP 2016 Meeting & Expo presentation on the value of developing and sharing electronic portfolios (ePortfolios) devoted to demonstrating your clinical research skills and accomplishments to current and potential employers, several experts today raised the utility of using the ePortfolio format for documenting and explicitly tying your experiences to the eight core […]