May 2008

Chinese Regulators, Pharma Industry Address Ethics Committee Challenges

Wednesday, May 28, 2008

A workshop held recently in Beijing presented an overview of the current ethical considerations and procedures for effectively designing, conducting and registering clinical trials in China. A key focus was clarifying the working procedures and challenges for ethics committees, also called institutional review boards, in China.

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eClinical Roundup

Tuesday, May 27, 2008

San Ramon, Calif.-based clinical software company Nextrials stated its 2007 revenues jumped 80% from an increase in multi-study contracts and its efforts in tapping into the medical device market. The company’s main clinical trial management software (CTMS), called PRISM, was used by various device sponsors including CardioMEMS, EKOS, Z-Tech Medical and Gynesonics.

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Pharm-Olam Opens Third Office in Russia

Friday, May 23, 2008

Houston, Texas-based CRO Pharm-Olam International, along with its sister-company MB Quest, opened a new office in St. Petersburg, Russia. The office is Pharm-Olam’s third location in the country to date, after expanding into Moscow and Novosibirsk. The new office is set to house 20 clinical staff by the fourth quarter of 2008. The company stated it has been conducting studies in Russia since 1997, but was using regional employees to monitor trials in St. Petersburg. 

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CDER’s Woodcock Details Expanded Authority at Post-Approval Summit

Friday, May 16, 2008

Opening the Post-Approval Summit at Harvard on May 14 and 15, keynote speaker Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), outlined her agency’s expanded authorities in the area of post-approval research oversight brought about by the passage of the FDA Amendments Act (FDAAA) into law at the end of March.

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eResearch’s Profits Soar

Thursday, May 15, 2008

Philadephia, Penn.-based eClinical company eResearch Technology (eRT) saw nearly a 60% increase in its first quarter revenues with $33.7 million compared to $21.1 million in the first quarter of 2007. Its net income soared 155.6% to $5.7 million (or $0.11 per share) from $2.2 million (or $0.04) a year earlier.

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