Icon, a provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has launched a new electronic system that will accelerate the review of cardiovascular (CV) events that occur during diabetes trials.
The Dublin, Ireland-based company said that 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 CV events, including cardiac death, acute MI and stroke. FDA guidance applies to diabetes drugs evaluated in all Phase II and Phase III trials and some Phase IV trials.
Icon said its new electronic solution, which is currently being used in a number of trials, allows CV event data to be uploaded, reviewed and assessed online.