Nextrials, a provider of electronic data capture, has become a registered provider of services conforming to the Clinical Data Interchange Standards Consortium (CDISC) standards. The San Francisco firm is the only one in the industry that's been vetted on CDISC's new Healthcare Link Initiative. The company says its technology to connect industry research systems to federally subsidized electronic health record (EHR) systems “is also the only platform successfully used in a multi-site study where real-time, live patient data was collected and shared by what had previously been two disparate data management platforms” for connecting to physician and hospital computers.

SpineMark signed a deal to support trials for Ranier Technology, a lumbar disc manufacturer based in Britain. "I am delighted to be working with SpineMark. Their specialized dedication to clinical research in spine, their relationships, and their ability to manage various aspects of the U.S. clinical trial process makes them a perfect fit for our study," said Geoffrey Andrews, CEO of Ranier. Here’s a news release and a ClinPage story on SpineMark.

Apcer Pharma, a regulatory affairs and pharmacovigilance-oriented outsourcing firm, announced it had won six new clients in the past three months. Here’s a release.

Johnson & Johnson continued to use off-label promotion to sell its blockbuster Risperdal antipsychotic to seniors even after being warned not to do so by the FDA. That's the allegation in these Business Week and Bloomberg articles. An industry critic in academia terms the allegations in ongoing class-action litigation "one of the more egregious examples" of the industry targeting vulnerable patient populations.

There is a draft of the second edition of an important how-to guide for post-marketing research, the Registries for Evaluating Patient Outcomes published by the the U.S. Agency for Healthcare Research and Quality (AHRQ). Comments via the agency’s website are open online until the end of the month.

Icon has added an office in Manilla. The expansion into the Philippines means the firm has 800 staffers in 14 Asian nations. Said Peter Gray, CEO: “[The] Philippines’ large population, coupled with the country’s well-established network of hospitals, physicians and investigators has made it an attractive location for our clients, and one which we have supported for a number of years through home-based employees.” Here’s a news release.

The honor and mathematical sophistication of many life science researchers are in doubt, according to statistical experts in the field quoted in this article. P-values and confidence intervals, it seems, are pervasively misunderstood and misused. There are two small consolations. Statistical errors and misunderstandings in the medical literature are mostly a result of general ignorance and incompetence—not systematic white-collar crime, as is the case in the U.S. financial sector. And Bayesian methods, if more widely used, could provide more credible research answers than the more-common frequentist approaches.

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