FDA

Coast IRB to Close in Wake of GAO Investigation

Monday, April 27, 2009 09:31 AM

Coast IRB, the institutional review board (IRB) that was the target of an undercover investigation by the Government Accountability Office (GAO), is closing its doors, according to reports published last week.

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Coast IRB Halts New Study Submissions

Wednesday, April 15, 2009 07:53 AM

Facing FDA concerns about its ability to protect human subjects participating in clinical trials, Coast Institutional Review Board has voluntarily suspended the approval of new studies as well as the recruitment of new patients for ongoing studies.

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IRB Uncovers Congressional 'Sting' Operation

Monday, March 23, 2009 09:00 AM

Source: Coast IRB

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Guest Commentary: Suicidality Monitoring in Pharmaceutical Clinical Trials

Friday, March 20, 2009 08:00 AM

Dr. Michael McKelvey, CEO of ERT , a leading provider of centralized ECG and eClinical technology, ePRO, and other services to the biopharmaceutical, medical device, and related industries, discusses the benefits of electronic patient reported outcomes (ePRO) tools for assessing and monitoring suicidality in clinical drug trials.

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Duke, NEJM Study Renews Debate on Global Outsourcing

Thursday, February 19, 2009 04:29 PM

The ethics and safety behind the global outsourcing of clinical trials is once again being debated, with the release of a new study reporting that U.S. drug developers conduct most of their late-stage drug trials outside of the United States.

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Guest Commentary: Setting Up Successful Investigator Meetings in Eastern Europe

Tuesday, December 16, 2008 08:00 AM

According to the August issue of The Centerwatch Monthly, the number of investigators in Central and Eastern Europe who filed Form FDA 1572s last year was close to 3,000, which means investigator participation in global clinical trials conducted in the region was up 25% over the prior year’s. Sponsors and global project managers from Western countries are managing teams and investigators from this region, and it is important for them to understand the specifics of this process.

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SFDA, Big Pharma Share Concerns at Shanghai Conference

Monday, November 24, 2008 09:00 AM

In his regulatory keynote address at the China Trials 2008 conference in Shanghai, Dr. Yi Feng, director, Office of Review Management, Center for Drug Evaluation (CDE), State Food and Drug Administration (SFDA) gave a broad overview of the evolution of global clinical trials in China and pinpointed future trends and goals in the country.

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Rural Population Key to China’s Clinical Research Market

Friday, November 21, 2008 11:37 AM

In his presentation at China Trials 2008 in Shanghai, “Conducting Global Post-Marketing Surveillance Studies in China—Opportunity and Practical Issues,” Mark Engel, president and chairman of Excel PharmaStudies, a large China-based contract research organization, identified two megatrends that will drive post-marketing surveillance studies to China: the rapid aging of its population and its increasingly insured rural population.

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DIA Opens Beijing Office

Wednesday, November 19, 2008 11:13 AM

The Drug Information Association (DIA) has expanded its worldwide operations by opening an office in Beijing, China. Headquartered in Horsham, Pa., DIA has regional offices in Switzerland, Japan, and now China.

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Preclinical CROs Expand Operations to Shanghai

Monday, October 27, 2008 09:36 AM

China has seen significant growth in the area of drug research and development in the past few years, and this growth will continue into the fourth quarter of 2008 with the opening of two new preclinical facilities in Shanghai.

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