— DSG’s Electronic Data Capture, IWRS and data management services used for XIAFLEX® program to support sBLA for Peyronie’s Disease —
MALVERN, Pa., Oct. 8, 2012— Auxilium Pharmaceuticals, a leading company focused on products for urology and sexual health, has selected DSG’s eCaseLink™ as its provider for electronic data capture (EDC). Auxilium will also use DSG’s interactive web response system (IWRS) and clinical data management services for supporting the submission of a supplemental Biologics License Application (sBLA) to the FDA for their XIAFLEX® program in Peyronie’s Disease by end of 2012.
Auxilium deployed DSG technology and services in the global studies on the safety and efficacy of XIAFLEX®, a novel, in-office, first-in-class biologic therapy for the treatment of Peyronie's disease.
“Working successfully with DSG in the past, we found that eCaseLink is a flexible and cost-effective solution for our studies,” said Dr. James Tursi, Chief Medical Officer at Auxilium Pharmaceuticals. “DSG’
DSG’s proprietary eCaseLink EDC system operates differently from all others, providing the friendliest and fastest data collection while dramatically reducing the volume of queries, simplifying the data management effort, reducing costs, and consistently leading to the most rapid Auxilium clinical data base locks.
“DSG is proud to partner with Auxilium on this program and looks forward to a successful sBLA submission,”
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences. Auxilium markets Testim® 1% (testosterone gel) for the topical treatment of hypogonadism in the U.S. and XIAFLEX® (collagenase clostridium histolyticum)
DSG, Inc. supports clinical trial data collection and management with innovative technology solutions, including Electronic Data Capture with specialized Clinical Data Management services, IWRS, Clinical Trial Management Systems and digital on-demand Case Report Form publishing management software. DSG’s products allow user-friendly, accurate and efficient data capture at any investigator site regardless of the technological infrastructure. DSG has successfully supported over 1,000 clinical trials for more than 400 companies at over 25,000 sites in more than 90 countries. Founded in 1992, DSG is a global company headquartered in Malvern, Pa., with additional offices in the U.S., Japan and India. For more information, please visit www.dsg-us.com.
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