Aetna, Covance and GNS Healthcare are joining forces to use so-called big data software tools to create a model of diabetes. In plainer English, they'll mine large numbers of medical records in an effort to link individual health status, prescribed medications and treatment outcomes. "Using data, we will now know very quickly which of these strategies works…more...

FDA surveillance of its own employees was approved by agency lawyers. Some of the intercepted communications may have been with Washington politicians. The surveillance program is no longer ongoing, but unearthed some 80,000 pages of documents, some of which were inadvertently posted online by an FDA contractor. Here are articles from Slate and the Washington PostIs…more...

Every year, across the globe, hundreds of new companies enter clinical development. Venture capitalists, academic scientists, refugees from big pharma—all of them invigorate and enliven industry science. But awareness of best practices in clinical development isn't always evenly distributed. Certain domains of knowledge (command of a therapeutic area, say) seem to be more comprehensively represented in young…more...

Roche and its biotechnology division in California, Genentech, failed to report or analyze approximately 103,000 adverse events and 15,000 deaths. In an apparent breach of regulations on both sides of the Atlantic, the firm had been supplying needy patients with treatment on compassionate grounds but never processed any of the associated data. "Possible side-effects picked up by…more...

Is the industry’s reliance on me-too drugs on the verge of reversing? Could pharma be on the cusp of a new cycle of innovation? That’s the possibility raised by Ian Lloyd. He has been studying industrial R&D for more than 20 years and currently serves as editorial director of Citeline, part of the Informa empire of trade…more...

Hedge funds have been making waves in the clinical development industry for years, snapping up contract research organizations (CRO) with publicly-listed shares and putting them in private hands. Now the game appears to be shifting to undervalued technology firms. Genstar finalized the $400 million purchase of ERT, the #1 cardiac core lab, earlier this month. This week,…more...

As far back as the late 1800s, when the eclinical landscape was an infant, all of the savvy companies paying for clinical trials agreed on one thing. Every research system for every trial must have its own database. This seemed smart at the time. Randomization data? Its own database. Case report form (CRF) data? Separate database. Monitoring…more...