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ICON Delivers New Electronic Solution to Expedite Clinical Trial Adjudication
Date:1/26/2009

DUBLIN, Ireland, January 26 /PRNewswire-FirstCall/ -- ICON plc, (NASDAQ: ICLR; ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the launch of a new electronic solution that will accelerate the adjudication of cardiovascular events in diabetes studies.

The evaluation of cardiovascular risk in diabetic trials has been the subject of recent FDA guidance. Recommendations published in December 2008 require sponsors to establish an independent cardiovascular endpoints committee to adjudicate cardiovascular events, including cardiac death, acute myocardial infarction and stroke. FDA guidance applies to diabetes drugs evaluated in all Phase II and Phase III trials and some Phase IV trials. Historically, most of the adjudication performed by independent adjudication committees has been done in a paper-based environment, causing inefficiencies in project tracking and data evaluation, auditing challenges and increased costs associated with adjudicator travel, shipping and unnecessary patient enrolment. ICON's new electronic solution, which is currently being used in a number of trials, allows cardiovascular event data to be uploaded, reviewed and assessed online, delivering significant operational efficiencies.

Dr. Jonathan Goldman, MD, FACC, Chief Medical Officer at ICON Medical Imaging commented: "ICON's electronic adjudication solution provides the most secure and accurate method of defining true cardiovascular events in real-time. Because of its inherent regulatory compliance it is ideally suited to comply with the recent FDA guidelines for diabetes trials. It also provides significant savings in costs and timelines by preventing unnecessary enrolment of patients once the target number of endpoints has been achie
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SOURCE ICON plc
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