Ethics/Regulatory

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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Pfizer is First Pharma Company to Receive AAHRPP Accreditation

Tuesday, April 7, 2009 08:00 AM

Pfizer is the first pharmaceutical company to be accredited by the Association for the Accreditation of Human Research Protection Programs. Pfizer (and its phase I clinical research units) was among 16 organizations to receive accreditation this quarter, bringing the total number of AAHRPP-accredited organizations to 175.

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PMDA’s New Five-Year Plan Under Way Today

Wednesday, April 1, 2009 08:00 AM

Japan’s regulatory authority, Pharmaceuticals and Medical Devices Agency (PMDA), is launching several new initiatives in fiscal year 2009, which begins today. PMDA representatives were out in force at the DIA EuroMeeting in Berlin last week to explain the new programs, which will be implemented between fiscal year 2009 and fiscal year 2013.

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IRB Uncovers Congressional 'Sting' Operation

Monday, March 23, 2009 09:00 AM

Source: Coast IRB

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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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CenterWatch Monthly February 2009

Tuesday, February 3, 2009 08:00 AM

Japan’s Global CT Push Boosts CROs, EDC

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CenterWatch Monthly January 2009

Wednesday, January 7, 2009 08:00 AM

Japan’s Global Clinical Trials Initiations Skyrocket

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AAHRPP Accredits 21 More Research Organizations

Tuesday, December 23, 2008 12:00 PM

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredited another 21 organizations in the fourth quarter, bringing its total number of accreditations this year to 67—more than any other single year since the association was founded in 2001.

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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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ACRP Partners with Shanghai Clinical Research Center

Thursday, December 11, 2008 09:10 AM

The Association of Clinical Research Professionals (ACRP) has partnered with the Shanghai Clinical Research Center (SCRC) to promote ACRP training and certification throughout China.

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