Veeda Clinical Research, a full service contract research organization, announced the launch of a global oncology CRO. Veeda Oncology aims to provide oncology clinical research services internationally. Said Binoy Gardi, group MD at Veeda Clinical Research: “Since July 1, 2007, we have been establishing the infrastructure for a global oncology CRO and today we are pleased to announce that both the personnel and technical infrastructure are in place, validated and tested.”

Replidyne stopped a clinical trial for financial reasons. “In the interest of conserving our financial position, we have made a difficult decision to discontinue enrollment in this faropenem trial,” said Kenneth Collins, president and CEO. Here’s the release.

Premier Research Group, a pharmaceutical services group, and Octagon Research Solutions, a process-centric solutions provider, announced the formalization of a partnership. It combines Octagon’s expertise in electronic submissions with Premier Research’s extensive clinical expertise across a wide array of therapeutic areas. Premier Research will offer Octagon’s electronic submission capabilities as part of its regulatory affairs services; Octagon will promote Premier’s services in regulatory development and scientific strategy. “Premier Research has a solid history of consistent, quality delivery that aligns with our own high standard of operation.  We believe that the collaboration will ultimately provide a strong product for our valued customers”, said Jim Walker, chairman and CEO, Octagon Research Solutions.

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Could the FDA’s reputation be destined for significantly lower depths? That’s our random guess after Congressional hearings on contaminated Baxter heparin. Dim-bulb lawyers in both parties who have never given the FDA adequate resources may be engaged in a two-part effort to a) tear down the agency first and b) rebuild it later. Here’s a wire-service story.

Synexus, an organization that recruits and runs clinical trials, achieved a new record by enrolling more than 10,000 patients in late stage clinical trials at 14 sites in six countries. Synexus is finding that its “hub site” model reduces costs, increases the quality of the data and speeds up recruitment. (Here’s our look at the company.) The company says that more than 25 clinical trials in a variety of therapeutic areas (osteoporosis, hypertension, cancer prevention, diabetes, sexual dysfunction, cardiac disease, urinary incontinence, migraine and osteoarthritis) are currently being supported in countries such as Poland, UK, India, Hungary, Bulgaria, and South Africa. Here’s the release. 

Adele Davis has been appointed as the head of clinical trials at BR Pharma, a developer of pharmaceutical products for comparator clinical trials and named patient programs. Davis will be responsible for managing operations of the company’s clinical trials procurement team and cultivating new business opportunities. “Adele’s worldwide clinical trial drug procurement expertise will be invaluable to BR Pharma and our U.S. business development arm,” said Rosemary Bensley, managing director of BR Pharma. Here’s the article.

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Clinical and Laboratory Standards Institute (CLSI) released the 2008 edition of Infobase, a searchable CD-ROM with more than 180 CLSI standards and guidelines for medical testing best practices. As one of the highlights of CLSI’s electronic product offerings, Infobase 2008 includes approved—and proposed—level documents with convenient search capabilities. Lola Pugliese, VP of finance and member services at CLSI, says, “We are pleased to announce the availability of the latest edition of Infobase. This user-friendly product is on a CD-ROM that our customers and members can have available at their computer in order to access and search CLSI documents to find practical solutions to day-to-day challenges.” Also available from CLSI is the Electronic Subscription Service, which offers access to the complete library of CLSI documents and is continuously updated.

Glaxo SmithKline (GSK) endorsed statistical tools from Insightful. “We are committed to this S-Plus graphics solution to assist our statisticians and scientists in understanding our data, and to improve the communication of results,” said Roger Liddle, VP of discovery biometrics at GSK. “As of the end of 2007, we have over 200 statisticians, programmers and epidemiologists trained. The clinical graphics our staff are producing are being used by GSK statisticians, clinicians, and publishing staff in several critical areas, including data analysis, presentation, submission, and publication.” Here’s an earlier ClinPage story on the statistics firm and the news release.

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