Vince & Associates Clinical Research, a clinical research services company based in Overland Park, Kan., has been awarded a contract with the FDA’s Center for Drug Evaluation and Research (CDER) to conduct bioequivalence studies of innovator and generic drugs such as anti-epileptic drugs.
The five-year contract will have a ceiling value of $5 million. Vince & Associates will conduct the studies and provide services including study design, protocol development and subject recruitment. In addition, Vince & Associates will participate in the clinical conduct of the studies.
“With this contract we will seek to investigate the bioequivalence of generic products that have resulted in reports of adverse events to the FDA,” said Brad Vince, president and medical director of Vince & Associates Clinical Research. “We are truly excited to partner with the FDA to help address agency concerns with product substitution issues.”