Clinical Test Expert Joins MD&DI’s Editorial Board

NEWS TRENDS

The staff of MD&DI is pleased to announce the appointment of Nancy J. Stark, PhD, to its Editorial Advisory Board. Stark has more than 25 years of experience in clinical research and biological safety testing. She is president and founder of Chicago-based Clinical Device Group Inc., a contract research organization specializing in medical device preapproval issues. The company also runs an active Web-based training program.

“Conducting clinical research and biological safety tests, both in the United States and abroad, can be daunting as well as confusing,” Stark says. “I help companies navigate the regulatory pathway of such trials, with an emphasis on obtaining data that will be usable and acceptable to FDA during the premarket approval application process.” She negotiates contracts for clinical research and biological safety evaluations to be fulfilled by a network of subcontrators.

Before founding Clinical Device Group, Stark served as manager of medical affairs at Hollister Inc. (Libertyville, IL), where she managed its clinical research and biological safety testing programs. Prior to that, she supervised similar programs for selected devices in the medical products division of 3M.

Stark is a member of the Association for Clinical Research Professionals, the Society of Clinical Research Associates, and the Regulatory Affairs Professionals Society. She received her PhD in biochemistry from the University of Minnesota and her BS in chemistry from the University of Nebraska. She has published 12 books and has given more than 40 industry lectures.