OVERLAND PARK, Kan.--(Vince & Associates Clinical Research today announced that it has been awarded a contract with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), to conduct bioequivalence studies of innovator and generic drugs such as anti-epileptic drugs.)--
“With this contract we will seek to investigate the bioequivalence of generic products that have resulted in reports of Adverse Events to the FDA”
This awards Vince & Associates a five-year contract with 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 Dr. 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.”
The project described was supported by Award # HHSF223201210030I from the FDA. The content is solely the responsibility of the authors and does not necessarily represent the official views of FDA, CDER.
About Vince & Associates Clinical Research
Vince & Associates Clinical Research has provided clinical research services to the biopharmaceutical industry for more than a decade. The research professionals at Vince & Associates are proud to be recognized in the industry as a “Center of Research Excellence.” Vince & Associates has become a premier clinical research site by utilizing The Physician Research Model® of operation where study teams are led by highly experienced Principal Investigators intricately involved in all aspects of the clinical trial process.
Vince & Associates recently opened a state–of–the–art, multi–million dollar, 90 bed Clinical Pharmacology Unit that combines the ultimate in subject safety and luxury. Boutique hotel level amenities of the facility feature 10 uniquely designed research suites. The 20” bedside touch–screen entertainment systems allow study volunteers individual access to watch TV and movies, surf the internet or play a host of games. This new unit has the upscale atmosphere necessary for the recruitment and retention of study volunteers in both short and long–term clinical trials. From the safety and security of the controlled access unit to the added features of a movie theater and game rooms, no detail has been overlooked.
Additional background materials pertaining to Vince & Associates Clinical Research are located on the corporate website at www.vinceandassociates.com.