Phase Forward’s flagship electronic data capture software won a Codie award for best medical and health information product. This year six hundred companies submitted 1,100 entries, which were judged by the Software & Information Industry Association (SIIA). “The 2008 Codie awards recognize those companies providing the best new technology products and services across a broad array of industries,” noted Ken Wasch, SIIA president. Here’s the release.

The FDA is considering changes to how drug labels advise pregnant women. Here’s a wire service story and a page about the topic at the FDA website.

Merck won an appeal of a massive $253 million verdict in Texas—the case that had been the first Vioxx-related matter to go to trial. An appeals court said the jury didn’t have the authority to determine if the company defrauded the FDA. The new ruling will itself be appealed, but could nudge plaintiffs who have not yet decided whether to join the company’s $5 billion class action settlement. Here’s what the company said.

ThreeWire, a patient recruitment firm, has brought aboard two new executives. Janine Katz is a business development professional with over ten years of experience in clinical trial patient recruitment and public relations programs in the pharmaceutical and health care industries. Shannon McDonnell brings leadership skills in business development in the health care field, including two years focused solely on clinical trial recruitment. “Successful enrollment solutions depend on a systematic marketing approach, which is exactly what ThreeWire offers,” says Jim Suddendorf, senior VP, business development. Here’s the release.

ClearTrial, a provider of clinical trial software for clinical operations planning, budgeting and outsourcing, announced that its managing partner, Richard Musselman, will share proven strategies for strengthening sponsor/CRO (contract research organization) relationships at the upcoming conference: “Critical hand-offs: effective alliance management and the project management interface.” The Cambridge Healthtech Institute (CHI) event, taking place this week at the Park Hyatt Philadelphia hotel, will provide tools, techniques and best practices for building effective sponsor/CRO alliances.

INC Research, a contract research organization (CRO), announced the launch of its women’s health division. Cynthia Madden will head the group. The division will be a provider of multi-therapeutic women’s health drug development services. Madden is board-certified in emergency medicine and completed an additional residency in preventive medicine. “By utilizing our trusted process methodology, INC Research has already developed a solid reputation for the successful conduct of clinical trials in women’s health such as breast cancer trials in our oncology division and fibromyalgia trials in our CNS division,” said John Potthoff, COO of INC Research.  Here’s the release.

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