Ethics/Regulatory

Duke, NEJM Study Renews Debate on Global Outsourcing

Thursday, February 19, 2009

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

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

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 (CFDA) 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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