Almac will distribute quality of life assessments from Facit.org. David Cella, president of Facit.org, said: "We are excited about the potential of our relationship with Almac Clinical Technologies. Partnerships such as these help streamline the inclusion of valid patient-reported-outcome tools into clinical trials efficiently and accurately." Here's a release.
Icon Clinical cofounder John Climax, who held the chairman title and helped build the firm into a global powerhouse, has retired. Climax will remain on the company's board. Here's a release. The firm's new chairman is Bruce Given, a physician with senior executive experience in small pharma and JNJ.
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Quintiles told the cash-strapped state of North Carolina to temporarily defer the payment of a $300,000 job-creation bonus. Under a 2006 deal to retain jobs near its Durham headquarters, the top contract research organization would be entitled to the bonus if it created 116 jobs paying $59,000 annually. The firm easily beat that target, creating almost four times as many jobs with an average salary of $81,000. Here's a story.
Epilepsy patients in the U.K. will be able to use text messages and the internet to record their symptoms and communicate with health care professionals, according to this story. As best we can tell, the project is in a context of routine patient care, not research. The vendor is iplato, with offices in London and the Czech Republic.
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Is there anything special about clinical data management that multinational IT firms can't handle? Apparently not. AstraZeneca has slashed its data management head count by 59 percent, according to this article in a British IT publication. Previously 1,100 people at the big pharma were devoted to data management. Now, with help from outsourcing firm Cognizant, a total of 350 people at AZ and Cognizant do the same work.
The FDA is telling the news media that it might impose new requirements on clinical trials of medical devices. The agency's Jeff Shuren, acting head of the FDA center for devices and radiological health, is leading the effort. Some academics believe 40 percent of medical device trials lack strong data about safety or efficacy. Any change could represent a significant new direction for research on medical devices. But once the usual lobbying around new regulations draws to a close, it could still take 20-30 years or more for the rhetoric to become policy. Here are articles by Bloomberg, the New York Times, and an abstract in JAMA.
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