IRVINE, CA--(Marketwire - August 03, 2010) -
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Research recently completed by the Tufts Center for the Study of Drug Development linked clinical study complexity to increased research costs. Tufts researchers found, for example, the median number of procedures per clinical trial increased by 49% between 2000-03 and 2004-07. The total effort required to complete those procedures grew by 54%.
Therapeutic expertise is one of the most effective ways clinical research organizations (CROs) can help biopharmaceutical and medical device companies contain clinical trial costs, according to Ray Dawkins, MD, Executive Medical Director at Paragon Biomedical.
Dawkins said therapeutic expertise often makes the difference between success and failure in complex clinical trials, including those investigating medical devices.
“A project manager knowledgeable about a therapeutic area is better equipped to identify and control risk than a project manager who lacks specific expertise,” said Dawkins. “Even though the biopharmaceutical and medical device markets are improving, our clients still demand the skills and insights needed to navigate within an increasingly complex environment. There is too much riding on a given study or program to put it in the hands of an inexperienced team.”
Dawkins’ expertise crosses major therapeutic areas, including cardiovascular, infectious disease, endocrinology, gastroenterology, and research in plasma-derived proteins and products. His recent work includes medical device research and development for delivery systems and new intravascular catheters for peripheral arterial disease and stroke.
Paragon Biomedical’s expertise includes management of one of the largest randomized trials of drug-eluting stents completed thus far.
Paragon Biomedical is a global, full-service CRO providing Phase I through IV clinical research services and clinical trial support to the world’s pharmaceutical, biotechnology, and medical device companies.
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