Almac announced improvements to its randomization and drug supply management system. Randomization for clinical research thus appears to be moving into an era of modern technology, not phone-based code that is decades old. In a statement, the company said: "Almac’s intuitive and user-friendly aXcess system gives clients the full benefit of a web-based randomization system, including state of the art reporting functionalities, shorter timelines for system build, and a price point to fit tight study budgets." Almac appears to be aware of a similar offering from IVR technology leader BioClinica. Here's more information from the Almac website.

FDA chief Margaret Hamburg told CNBC and a generic drug conference that she'd like to cut the review time for generic applications from 30 months to 10 months. She did not disclose the timeline under which the backlog could be reduced. Nor is it clear if FDA already has the necessary resources to do so. There are 2,500 generic applications waiting in the review pipeline at the agency, and the review time has doubled over the past few years.

The Clinical Data Interchange Standards Consortium (CDISC) is working on guidelines for companies researching medical devices. The goal is to establish additional data collection fields, submission variables, types of metadata and other IT magic to help developers of diagnostic, implantable and imaging devices. "These seven new proposed SDTM Device domains are a major milestone," said Roche's Carey Smoak, co-leader of the CDISC devices team. “We encourage review from the clinical research community in the effort to ensure that this draft standard effectively meets the needs of all audiences.” Here's a news announcement and a bulletin from the CDISC website.

We dimly but fondly remember the first meeting about government registries for industry trials. Next month, CBI is hosting the seventh annual gathering of the Clinical Trials Registries and Results Databases meeting on April 24-5 in Philadelphia. Two highlights include Rob Middel, global head of operations at Johnson & Johnson; and Merete Jørgensen, director of global clinical registry at Novo Nordisk.

Electronic data capture supplier DataTrak announced financial results. Net service revenue fell 12 percent, to $1.5 million. The company swung from a small profit to a $434,000 loss. But on the whole, the Ohio firm said, things are looking up. During 2011, the count of its new clients rose 50 percent; the number of contract research organization (CRO) clients have nearly tripled. Here's a release. WIth a Chinese partner, DataTrak has also launched its first trial in a dialect it calls "Simplified Chinese." Your correspondent is acquainted with people who could communicate more effectively using "Simplified English," but we digress.

Canada is having trouble with low or nonexistent supplies of key drugs, according to this article. Provincial officials in Ottawa are establishing a registry to track shortages of medications for pain and cancer. When it comes to availability of some medications, the distinction between developed and developing countries may be blurring.

Pfizer is making midcourse adjustments to a formerly internet-only patient recruitment process that we covered here last year. The security measures needed to establish a patient's identity were apparently too onerous, leading to a project delay. Solution? The big firm has added a low-tech telephone call center with human beings answering the phones.

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