MORRISVILLE, N.C. …Â REPLACE-2, a clinical trial of The Medicines Company’s Angiomax (bivalirudin), exclusively employed a web-based data capture system developed by etrials Worldwide, making it the largest “paperless” clinical trial ever completed by etrials, which develops eClinical software for the collection, integration and review of data in the clinical trial process.
All 233 clinical trial sites in the United States, Canada, western Europe and Israel employed a real-time data entry system that was web-based and included etrials’ QuickStudy Capture electronic data capture (EDC) technology and QuickStudy Touch services. The data in REPLACE-2 was collected and entered rapidly, as the enrollment of more than 6,000 patients was completed in less than one year.
Following the completion of target enrollment and 30-day patient follow-up in late September, the trial organizers were able to complete data entry, lock the database and prepare the data for a late-breaking presentation at the American Heart Association’s Scientific Sessions 2002. The study data included 498 questions, or over 3 million data points and more than 500 edit checks. The process of final data collection and adjudication, which usually takes a matter of months, was completed in less than four weeks with etrials’ assistance.
“The Medicines Company recognized the importance of efficiency and solving the issues associated with paper in clinical trials, and we are thrilled that they were able to meet or exceed their timeline goals through the use of etrials’ technology and services,” etrials Chief Executive John Cline said in a statement.
etrials Worldwide: www.etrials.com