Kendle launched a new system for biostatistics. According to the news release, the platform is based on SAS and will be used by a growing team of Kendle personnel in India. "Data will be processed at the server level much faster than ever before, greatly improving the productivity of our teams around the world and expediting the delivery of quality data to our customers," said John Whitaker, VP of biostatistics and statistical programming. "This investment allows Kendle to provide a more globally integrated solution to meet our customers' needs anywhere, any time."

There's a nearly final agenda for the Post Approval Summit. The event will be held on May 11-12 at Harvard's Boston medical school campus; it is organized and sponsored by Outcome, a technology firm specializing in post-approval projects. The meeting attracts unusually high-profile speakers from the sponsor and regulatory worlds. One highlight this year is Michael Rosenblatt, executive VP and chief medical officer at Merck. As of today, registration for the meeting is still open and discounted.

Acurian says that it is gathering more than half of its patients using social networking websites like Facebook and other electronic forums. "The fact that the majority of our patient referrals are coming from web-based efforts illustrates how Acurian has continued to broaden and hone our online capabilities,” says Roger Smith, the firm's senior VP of operations. Our article on the firm is here.

Despite what you may think, Quintiles is no longer a contract research organization (CRO). The firm is recategorizing itself as a "pharmaceutical services organization." The company is still doing clinical outsourcing. It's still working on a few trials. But Quintiles insists that the breadth of its activities (which now include marketing drugs and privately investing in their development) warrant a new label that is part CRO, part sponsor. Here's a story.

Johnson & Johnson issued a warning letter about an artificial hip component the firm is already yanking from the market. The company blamed doctors for installing the so-called ASR hip incorrectly, according to the New York Times.

As of late last month, the FDA has a draft guidance on adaptive designs. The document codifies what a few leading sponsors have been doing for a decade, and will allow other firms to postpone modern trial designs for another decade while the guidance is discussed and revised. The lead FDA authors: Robert O’Neill, Sue-Jane Wang and Marc Walton. The agency defines key terminology and explores the implications of altering a trial's course by relying on data from within or outside the same project. But there appears to be new agency concern about sponsors delegating the analysis of interim results to contract research organizations. "Many CROs do not have long histories of carrying out these responsibilities," the document warns. Here's a link to a page with recent guidance documents in PDF form. DIA is also having a one-day meeting on the guidance at the end of this month.

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