BBK announced a new version of its software to manage patient recruitment campaigns. The firm released a new mobile application for customers with Blackberry and Apple smartphones. The software supports 12 different languages: Chinese, Dutch, English, French, German, Hindi, Italian, Japanese, Polish, Portuguese, Russian and Spanish. "The smart phone app provides immediate access to study-goal information, enrollment numbers, key dates, country information, and media metrics and study teams can now assess key data and make decisions on the go," said Sarah Mandracchia, the company's director of data management.

Two cardiologic trials of medical devices will continue despite the failure of a similar third trial sponsored by NMT Medical. One ongoing project is crediting an adaptive design. Here's an article.

Encorium, a contract research organization (CRO), will buy Progenitor, a Swiss CRO. The price: $2.2 million, with a potential additional $1.9 million in incentives. Here's a release.

The British government slashed its 2010 order for swine flu vaccine from GSK, cutting the number of doses from 90 million orders to 35 million. The media are trying to uncover the price being paid by British authorities. The UK officials won't pay a cancellation fee, but may face a higher price per dose. Here's an article.

The community around the open-source electronic data capture (EDC) solution Open Clinica has surpassed 10,000 members. The company behind the system, Akaza Research, says the user group has tripled in size over the past two years. Benjamin Baumann, co-founder and director of business development, added: "Trial sponsors, CROs, and academic centers using the commercially supported OpenClinica Enterprise Edition aren't burdened with per-study fees, and maintain more direct control over their study design. In many cases these are significant barriers to efficient adoption of EDC."

The FDA is worried about data falsification. A reader alerted us to a February, 2010 proposed rule. In brief, sponsors will have 45 days to report falsified trial data. Existing U.S. law and informal Good Clinical Practice (GCP) guidelines apparently have not been enough to keep industry truthful. "Some sponsors have discovered falsification of data and have been reluctant, or uncertain as to whether it was necessary, to report the information to us," the agency notes. The rule would apply only to deliberate omissions or falsification of data, not to inadvertent errors. The agency will exempt scientists working for federal agencies and focus on commercial drug and device "manufacturers" instead. But the notice refers to research conducted "on behalf of" sponsors, which presumably means CROs. d9A2t49mkex

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