Theorem Clinical Research Advances IDMC/DSMB and CEC Management Services with New Associate Director
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Sep 19, 2012--Theorem Clinical Research Inc., a full-service contract research organization (CRO) that provides core clinical research and development services, continues to propel its Independent Data Monitoring Committee (IDMC), Data Safety Monitoring Board ( DSMB ) and Clinical Endpoint/Event Committee (CEC) management services with added clinical oversight by Associate Director of Scientific Affairs Dr. Lisa Moore.
Since 2005, Theorem has recruited key opinion leaders in a variety of therapeutic and clinical research areas from around the world and has supported more than 200 meetings. With the current landscape leaning toward conduct of trials globally, Theorem has the ability to build committees with representatives from more than just the U.S. to ensure a balance of knowledge of local standards of care, language and practices.
“DSMB and CEC committees are being increasingly required by the Food and Drug Administration (FDA) in high-risk clinical trials,” said Dr. Lee Spurgin, Theorem senior vice president and general manager of medical device and diagnostic development. “With Dr. Moore’s leadership, we will continue to meet and exceed those requirements by providing committee experts for our clients.” Dr. Moore served multiple roles within Theorem during the past 20 years, most recently as the associate director of clinical development. She holds a doctorate in physiology from the University of Arizona and completed post doctoral training in cardiovascular physiology at the Albert Einstein College of Medicine and in airway physiology at the University of Massachusetts Medical Center.
According to Dr. Moore, potential committee members are meticulously screened for their expertise in clinical research, the study indication, prior experience in oversight activities and anything that might suggest a bias relating to a particular study.
“Our goal at Theorem is to always create committees that the FDA can have confidence in knowing that the panelists are experts and there is no conflict of interest,” she said.
About Theorem Clinical Research Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's leading pharmaceutical, biotech and medical device companies. A world leader in the most complex medical device and drug-device combination trials in addition to a notable capability in pharmaceuticals and biologics, Theorem has deep expertise in a broad range of therapeutic areas and in all phases of development. Some of the industry's top scientists and most advanced clinical analytics capabilities help ensure smooth-running, successful trials. For a full-service, right-size global research partner, don't think twice. THINK THEOREM.CONTACT: Theorem Clinical Research Shawn Clary, 484-679-2400 firstname.lastname@example.org KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS PHARMACEUTICAL RESEARCH SCIENCE SOURCE: Theorem Clinical Research Copyright Business Wire 2012 PUB: 09/19/2012 08:00 AM/DISC: 09/19/2012 08:00 AM http://www.businesswire.com/news/home/20120919005343/