Miscellaneous

inVentiv Clinical Moves into Latin America

Monday, March 24, 2008 05:12 AM

inVentiv Clinical, the contract research organization (CRO) division of Somerset, N.J.-based marketing, communications and staffing firm inVentiv Health, has expanded its clinical services to Latin America with a new central hub in Sao Paulo, Brazil. The company stated it plans to bolster its operations in other countries throughout the region as well.

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CWWeekly March 17th 2008 Issue

Friday, March 21, 2008 11:18 AM

Top News

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PRA Relocates to Larger India Office

Wednesday, March 19, 2008 03:02 PM

Raleigh, N.C.,-based PRA International has expanded its Mumbai, India, presence by moving into a larger facility. It is located in a new development in the Andheri East area of Mumbai. The new space can hold more than 20 clinical staff and allow for PRA to bring its total to 50 employees there by the end of the year. The company said this would potentially increase its service capacity by 150%. As the office grows, PRA will increase services in protocol development, medical writing and clinical consultation services in the region.

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eClinical Technology News

Tuesday, March 18, 2008 01:55 PM

Ft. Lauderdale, Fla.-based OmniComm Systems won a contract from Pleiad Devices, a medical device focused contract research organization. OmniComm will become a preferred vendor for Pleiad. The company will use OmniComm’s electronic data capture (EDC) product TrialMaster, initially for a trial studying an eye treatment. "Over the years, our team has had experience with most of the EDC vendors in the marketplace. TrialMaster is one of the best EDC products that we have seen and we look forward to offering our medical device customers this premier service," stated Stephen Brandao, vice president of business development at Pleiad Devices.

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CenterWatch Monthly March 2008 Issue

Monday, March 17, 2008 12:18 PM

Unanticipated Problems Reporting Adverse Events to IRBs

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Recent Industry Personnel Changes

Monday, March 17, 2008 06:30 AM

Contract Research

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CWWeekly March 10th 2008 Issue

Friday, March 14, 2008 10:30 AM

Top News

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Japan's New Regulatory Attitude Evident at DIA EuroMeeting

Wednesday, March 12, 2008 11:49 AM

One of the highlights of the DIA EuroMeeting in Barcelona certainly had to be the update from Japan’s regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA). The session was introduced by Yoshiaki Uyama, Ph.D, a review director at PMDA, who  was wearing a PMDA T-shirt, instead of a suit and tie, which admittedly seemed too casual. He explained that his luggage hadn’t arrived at the same time he had, which produced knowing laughter.

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RLS Drug Shows Promise in Pivotal Trial

Tuesday, March 11, 2008 02:04 PM

XenoPort and GlaxoSmithKline reported positive top-line results from a phase III trial of XP13512, a gabapentin pro-drug with enhanced absorption, for the treatment of moderate to severe restless legs syndrome. This 12-week, double-blind, placebo-controlled study, dubbed XP053, enrolled 325 subjects. The endpoints were met with statistical significance in both dose groups when compared to placebo.

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etrials' Reports $2.6M Loss

Monday, March 10, 2008 12:31 PM

Morrisville, N.C.-based etrials’ sales were up 17% during its 2007 fourth quarter. The eClinical company reported net service revenue was $4.9 million compared with $4.2 million in 2006. However, it reported a net loss for the fourth quarter of $2.6 million (or $0.24 per diluted share) compared with a net loss of $46,000 (or $0.00 per diluted share) in the fourth quarter of 2006.

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