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.”
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.
Malvern, Pa., March. 12, 2013
Listen to archived Federal News Radio Interview with Tony Varano from 3/12/2013 Washington, DC.
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.
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.
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.
Exton, Pa., Oct. 19, 2011 — Frontage 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.
DSG News Articles - 2010
Malvern, Pa., Dec. 13, 2010 — The Center for Neuroscience and Regenerative Medicine (CNRM) is using DSG’s eCaseLink™ EDC (electronic data capture) system in three key studies on traumatic brain injury (TBI) in an effort to properly classify, diagnose, and combat one of the leading medical issues for U.S. military troops and veterans.
Malvern, Pa., Feb. 01, 2010 — DSG‘s eCaseLink™ Electronic Data Capture (EDC) and data management are currently being used by a biotechnology company for two current Phase II and Phase IIa clinical trials for treatments of progressive and chronic kidney disease. The company uses DSG’s eCaseLink™ to automate and manage the data collection process during the clinical trial life cycle. In addition, DSG combines data management services with eCaseLink™ to seamlessly optimize data collection and analysis. The result is clean clinical trial data, collected and analyzed efficiently. This accelerates the clinical trial process, helping to safely speed these treatments to those who need them.
Malvern, Pa., Jan. 11, 2010 — DSG, a leader in electronic data capture (EDC) has teamed up with a leading-edge pharmaceutical company to speed the early detection of Alzheimer’s, Parkinson’s, and Diabetes. The focus is on developing molecular imaging products that are leading the way to the early detection of human diseases. DSG’s eCaseLink™ EDC (Electronic Data Capture) supports three current clinical trials for Alzheimer’s disease, Parkinson’s disease and Diabetes. eCaseLink™ supplies real-time capability to review case documents and metrics across all study sites, significantly increasing clinical trial management speed, while reducing study management costs by as much as 30 percent.