DSG in the News

News about DSG

Drug Approved In Pivotal Studies Using DSG’s eSource Data

Malvern, Pa., March. 04, 2015 — Many years before the FDA offered its eSource Guidance in September 2013, Sirion Therapeutics launched its first two pivotal Phase III studies using entirely electronic source data collection. In those trials for the safety and efficacy of Difluprednate for the management of inflammation following ocular surgery, Kim McLeod, former Vice President of Clinical Operations at Sirion and currently Director, Prospective Research at Xcenda, said, “Electronic source made the most practical and economic sense; however in researching the topic, we discovered a lack of FDA guidance, an absence of industry case studies, and no subject matter expertise such as consultants with experience in submitting a 100% electronic source study to the Agency.”

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Kythera Reports Positive Phase III Trial Data On Submental Fat Treatment.

Malvern, Pa., Sept. 18, 2013 — The Wall Street Journal reports biopharmaceutical firm Kythera Biopharmaceuticals Inc. reported positive Phase III results on two submental fat treatment trials. On Monday, the company announced the trials for its ATX-101 injectable, designed to reduce fat in the chin, had met all primary and secondary endpoints.

Reuters (9/17, Siddiqui) reports that more than 1,000 patients were enrolled in the two studies, which were conducted in Canada and the US.

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DSG founder & CEO Tony Varano on Fed Tech Talk with John Gilroy

Malvern, Pa., March. 12, 2013 Listen to the Federal News Radio interview with Tony Varano who discussed the latest developments in clinical trials, data management and regulatory issues on Fed Tech Talk, with award-winning host John Gilroy.

Tony Varano offered insights on how clinical trials are evolving, where the FDA continues its crucial role and how software companies like DSG are a key to success for pharmaceutical, biotech and medical device industries.

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Auxilium Pharmaceuticals selects DSG as EDC provider

Malvern, Pa., Oct. 08, 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.

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Ariosa Diagnostics selects DSG as EDC provider

Malvern, Pa., April 23, 2012— Ariosa Diagnostics, a molecular diagnostics company focused on prenatal testing, has chosen to use DSG’s eCaseLink EDC (electronic data capture) system for the NEXT (Non-Invasive Chromosomal Examination of Trisomy) study.

Frontage Cuts Time, Sharpens Accuracy of Clinical Data Collection by accessing DSG's eCaseLink 8.0

Exton, Pa., Oct. 19, 2011Frontage Laboratories, Inc. a global pharmaceutical contract research organization, now offers clients faster clinical trial data collection and increased accuracy through advanced electronic data capture (EDC) technology. Clinical research clients will benefit from a new strategic partnership between Frontage and DSG Inc., a pioneer of EDC solutions for pharmaceutical and biotech companies. Study coordinators working with Frontage Clinical Services worldwide now have access to DSG’s eCaseLink 8.0 EDC software system.

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