KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Oct 16, 2012--Within the upcoming weeks, Theorem Clinical Research Inc. experts will make several presentations about the recently streamlined de novo process, an alternative regulatory pathway to market, and the challenges of medical device clinical trials.
Theorem, a full-service contract research organization (CRO) provides core clinical research and development services and executes successful medical device trials across all risk classifications and approval pathways globally.
Theorem’s Vice President of Medical and Scientific Affairs, Medical Devices and Diagnostics, Evan L. Rosenfeld, M.D., J.D., F.C.L.M., will speak about the de novo process October 22 at BIOCOM in San Diego. He will also speak to the Orange County Regulatory Affairs ( OCRA ) Discussion Group October 24 in Irvine, Calif. Rosenfeld will discuss the difference between success and failure in the medical device business and the benefits and disadvantages of the de novo pathway.
According to Rosenfeld, the de novo process is a mechanism for down classification and subsequent 510(k) premarket clearance of low-to-medium risk products, and is a pathway that can improve overall efficiencies and lower the costs to reaching the U.S. marketplace.
In July 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act ( FDASIA ) that shortened and streamlined the previously lengthy and cumbersome de novo process into two steps. The changes are intended to allow companies to get to market much more quickly and without a lot of the prerequisites mandated under the prior law.
“The de novo regulatory process has the potential to affect the way businesses can go to market,” Rosenfeld said. “What used to take two to four years, now should take only 120 to 180 days.” Theorem’s Associate Director of Scientific Affairs and Medical Device Business Unit, Lisa Moore, RN, Ph.D., will present at the Model Agreements Guidelines International ( MAGI ) Clinical Research Conference October 21 in San Diego. Moore will be a part of a panel discussion on the challenges of conducting medical device trials and the value of oversight committees.
“From protocol design to reporting and timelines, upfront planning is needed in designing a clinical trial utilizing oversight groups,” she said. “Oversight committees provide unbiased, standardized safety and outcomes assessment and are the solution to providing quality safety monitoring and centralized endpoint review when conducting medical device trials.” Additionally, company representatives will be present at the Transcatheter Cardiovascular Therapeutics ( TCT ) Conference October 22-26 in Miami.
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 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 CALIFORNIA FLORIDA PENNSYLVANIA INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS MEDICAL DEVICES PHARMACEUTICAL RESEARCH FDA SCIENCE SOURCE: Theorem Clinical Research Inc. Copyright Business Wire 2012 PUB: 10/16/2012 08:00 AM/DISC: 10/16/2012 08:00 AM http://www.businesswire.com/news/home/20121016005319/