Patient diary firm CRF has shepherded some of its technology through the FDA registration process for medical devices. In a news release, the firm says it is the first among peers to do so: "TrialMax is categorized as a Class 1 MDDS under regulation 21 CFR 880.6310. And because it uses alarms to remind subjects when to take their study medication, it’s also classified as a ‘medication reminder’ under regulation 21 CFR 890.5050. This makes TrialMax exempt from pre-market review but still subject to medical device 21 CFR 820 quality standards, a practice to which CRF Health is fully compliant."

Although Europe has had generic versions of biotechnology products for years, the regulatory process in the U.S. has been stalled by industry lobbying and technical questions. Now a wire service story suggests the FDA and the Obama administration have quietly worked out a deal with the industry and are inching toward a formal regulatory document—although there are no clues about the timing of such a shift. This editorial in the New England Journal of Medicine, written by high-level FDA officials, is said to telegraph some of the agency's thinking.

Eclinical firm Merge Healthcare has selected the PC manufacturer Dell as a provider for its image-sharing network. "The combination of Merge and Dell enables secure and scalable onsite and cloud-based solutions that strengthen the coordination of patient care among healthcare stakeholders," said Jeff Surges, CEO of Merge.

PointCross has a new contract with the FDA's Center for Drug Evaluation and Research (CDER) to provide an electronic environment for nonclinical drug safety analysis. The software supports the Send standard of the Clinical Data Interchange Standards Consortium (CDISC). Said Suresh Madhavan, the CEO of PointCross, "The FDA's decision to procure our nonclinical study software suite is a reflection of our thought leadership in delivering strategic search, data integration and standards-driven solutions and services to the agency, the IMI eTox Consortium and some of the largest sponsor companies in the biopharma industry." There is a bit of additional information about the eTox effort in this subscription-only article. Pointcross is built around the Microsoft SharePoint platform and is also serving the petroleum industry.

Quintiles tapped Steven Skolsky as global head of its clinical and data operations division, which the company said comprises 5,000 people. Skolsky has previously worked in Europe and the U.S. at such firms as Sequoia Pharmaceuticals, Basilea, Adherex and GSK. “Steve’s deep knowledge of the industry and proven leadership capabilities will enable Quintiles to increase the value that we deliver to customers in today’s rapidly changing environment we call the New Health,” Paula Brown Stafford, president of clinical development, said in a news release.

Bio-Optronics updated its clinical trial management system (CTMS), which now processes payments to investigators and patients using integrated software and debit cards developed by the clinical trial payment pioneer Greenphire. (There is a ClinPage story about Greenphire here.) “We issued payments with paper checks before. Since implementing the ClinCard module within Clinical Conductor, we issue all subject stipends directly to their ClinCards. This saves us time, and we're able to recognize a more efficient use of money,” said Yvonne McCracken of Carolinas Research Associates. Here's a link to a news release.

PPD will be taken private for $3.9 billion by two hedge funds: The Carlyle Group and Hellman & Friedman. The deal took several months to finalize after summer news accounts of the early negotiations. The appeal of a steady, profitable, well-run global franchise like PPD in an uncertain economic climate was significant. The transaction represents a large 30 percent premium to the company's valuation prior to the deal, signaling that the new owners believe the company was undervalued by stock market investors. Whether the transaction turns out to be auspicious for PPD employees is less clear, especially if standard hedge fund practices are deployed to prepare the firm for another sale or re-entry to the public market down the road. Here's a news article and an announcement.

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