Ethics/Regulatory

FDA Inspecting Few Overseas Sites

Thursday, July 8, 2010 07:57 AM

More than three quarters of all clinical trial subjects were enrolled overseas, and yet the FDA inspected just 45 foreign investigative sites in 2008. That’s just 0.7% of all overseas sites that enrolled a trial subject.

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Doctor Sentenced to Six Months for Faking Study Results

Wednesday, July 7, 2010 07:57 AM

Scott Reuben, the Massachusetts doctor dubbed the medical equivalent of Bernie Madoff by Scientific American, was sentenced to six months in federal prison on June 24. His crime: faking favorable painkiller study results. Reuben pleaded guilty to one count of health care fraud in February.

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Regulatory Affairs Society Provides Regulatory Course Content to Chinese University

Tuesday, May 11, 2010 07:11 AM

The Regulatory Affairs Professionals Society (RAPS) signed an agreement with the University of Shanghai for Science and Technology (USST) to develop regulatory-focused educational content for the Chinese university.

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ACRP Certification for CRCs, CRAs Receives NCCA Accreditation

Monday, May 3, 2010 07:39 AM

Two certification programs offered by the Association of Clinical Research Professionals (ACRP) are now accredited by the National Commission for Certifying Agencies (NCCA).

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Pfizer Warned by FDA for Inadequate Monitoring in Peds Study

Friday, April 23, 2010 07:01 AM

Pfizer received a warning letter from the U.S. Food and Drug Administration (FDA) last week, citing the pharmaceutical giant for inadequate clinical trial monitoring in the study of a pediatric drug—violations that led to the overdosing of at least 26 children.

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Independent Review Consulting, Ethical Review Committee Complete Merger

Thursday, April 15, 2010 07:54 AM

California-based Independent Review Consulting (IRC) and Missouri-based Ethical Review Committee (ERC) finalized their merger agreement, creating one institutional review board (IRB)—Ethical and Independent Review Services (E&I). While the individual boards of each company will continue their review of existing clinical trials respectively, all new submissions of business will be accepted and managed by E&I.

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Total AAHRPP-Accredited Organizations Tops 200

Wednesday, March 31, 2010 06:54 AM

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredited six additional organizations, bringing the total number of AAHRPP-accredited organizations above 200. The latest accreditation recipients included three universities, two independent IRBs, and a teaching hospital system.

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Nextrials Gets CDISC Approval

Wednesday, March 24, 2010 08:47 AM

Nextrials, a clinical research software and services company, has been approved by the Clinical Data Interchange Standards Consortium (CDISC) as one of 15 registered solutions providers. It is the only company offering an electronic data capture (EDC) product supporting the CDISC Healthcare Link Initiative.

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FDA Issues Draft Guidance for IRBs Conducting Continuing Review

Wednesday, February 3, 2010 07:07 AM

The U.S. Food and Drug Administration (FDA) recently released draft guidance for institutional review board (IRB) continuing review—the first updates that the regulatory agency has provided for this process since it issued IRB regulations in 1981. 

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CenterWatch Monthly February 2010

Monday, February 1, 2010 07:57 AM

Second Wave of Sponsor, CRO Growth Hitting Asia-Pac

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