Avigen chose Qumas as its document management partner. Avigen will first implement QumasDocCompliance as its regulatory content management system for quality assurance and document control. Then it will use the system for regulatory affairs. Said Andrew Sauter, Avigen’s CFO: “As we prepare for the more rigorous regulatory demands of later-stage clinical development, we believe Qumas has the solutions and experience necessary to ensure our return on investment, and eliminate the need to manage disparate and isolated compliance systems.”

The unprecedented level of criticism of Emory University psychiatrist Charles Nemeroff continues. For those new to the story, Nemeroff appears to have failed to report hundreds of thousands of dollars in income from the pharmaceutical industry to a) his employer or b) NIH officials. Nemeroff’s adversaries in Congress and academia seem intent on ruining his illustrious career. It’s unclear why. One dynamic may be pent-up anger over past, unrelated industry campaigns to stifle academics responsible for research critical of drugs like Avandia or Vioxx. This article from the main Atlanta newspaper suggests Nemeroff had longtime enemies and one benefactor: former U.S. senator Sam Nunn, who is trying to repair his reputation. Meanwhile, the NIH has frozen a $9.3 million grant to the university as it investigates the mess, this story reports. Nemeroff’s high-profile patients include Ted Turner, the CNN founder.

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Mark Sutherland joined GenVault as senior VP of business development. He will be responsible for finding, prioritizing and closing significant opportunities for partnering and licensing the company’s products and technologies. “Mark’s great wealth of experience in the life sciences arena will be a very positive asset for GenVault,” said David Wellis, GenVault president and CEO. “Mark also brings deep relationships with a number of the companies we are looking to do business with in the coming years.”

Relatives of American military personnel charge that an antimalaria drug from Roche, Lariam (mefloquine hydrochloride), is implicated in suicide, a previously identified serious adverse event. But media accounts are implying indifference and incompetence at the Pentagon. The U.S. military prefers Lariam because its once-weekly dosage can be easily monitored by supervisors, ensuring soldiers don’t pocket their pills. It’s unclear whether antimalaria compounds are even needed in some environments where they are being used. Worse, military doctors prescribing antidepressants and Lariam to the same soldiers may not be aware of contraindications to that combination. We can see the ambulance-chasing lawyer ads already. Here’s a Washington Post article.

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Wooridul SpineMark has identified sites for five planned spine centers on four continents. It’s a joint venture of SpineMark of San Diego, Calif. and Wooridul Healthcare of Korea. The firms plan to open minimally invasive spine centers of excellence and fellowship training programs in Sao Paulo, Brazil; Tijuana, Mexico; Singapore City, Singapore; Barcelona, Spain; and Ankara, Turkey. “Spine injuries know no boundaries. They affect people young and old throughout the world. We formed the Wooridul SpineMark International alliance so patients could access sophisticated spine care treatments, no matter where in the world they live,” said Marcy Rogers, president and CEO of SpineMark. Here’s the release.

The Society for Clinical Data Management certified 330 clinical data managers. SCDM released version 2.0 of its Certified Clinical Data Manager (CCDM) exam worldwide through Prometric Testing Centers. The test was the result of seventeen months and 2,000 volunteer and staff hours incorporating changes within the industry since the exam’s first iteration in 2003. Experienced CCDMs wrote questions to assess competencies, which were then subjected to rigorous technical and fairness reviews, as well as a review by an independent panel of industry experts. In June of this year, more than 200 candidates tested the exam before its final release. “The CCDM program further elevates the role of the clinical data manager, putting it on par with other pharmaceutical research professionals. The acceptance of the CCDM designation by our clinical colleagues has been phenomenal,” said Angel Lazarov, director of data management at i3 Statprobe.

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