December 2007

eClinical Technology News

Wednesday, December 26, 2007

  • New York, N.Y.-based Medidata Solutions electronic data capture (EDC) won an agreement with Boston, Mass.-based CRO Parexel through the Medidata’s non-exclusive service provider model, ASPire to win. Medidata stated the CRO was attracted to Rave’s broad user acceptance, ease of deployment and real-time access to clinical data. Medidata Solutions also landed a contract with Dublin-based Elan Pharmaceuticals for the technology company’s Medidata Rave solution. Medidata stated that much of Elan’s data management operations is outsourced so it needed a product that could be easily adopted by any CRO regardless of past experience with the technology. Elan will use the solution for mid-to-late stage trials in North America.

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Premier Consolidates Expertise into One Consulting Unit

Wednesday, December 12, 2007

Philadelphia, Penn.-based Premier Research Group has consolidated its experts, including therapeutic leadership, medical device development, adaptive clinical trials design, and clinical trial informatics, into a single consulting group called Strategic Product Development (SPD) that will be led by Samer Kaba,M.D., vice president of SPD and global medical affairs.

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Platelet Growth Factor Hits Endpoints in Phase II

Tuesday, December 4, 2007

GlaxoSmithKline reported positive results from two phase II trials of Promacta — a non-peptide thrombopoietin receptor agonist (platelet growth factor) which can stimulate the growth and differentiation of bone marrow cells that priduce blood platelets — for the treatment of chronic hepatitis C-associated thrombocytopenia and chronic Idiopathic thrombocytopenic purpura (ITP). The first study was an international, multicenter, double-blind, randomized, placebo-controlled, dose-ranging study. A total of seventy-four HCV-infected subjects with platelet counts between 20,000 and 70,000/mL were enrolled. The subjects received Promacta (30mg, 50mg, or 75mg daily) or placebo for four weeks (pre-antiviral phase).

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