FDA

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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SAFE-BioPharma Signing up Sites, CROs

Wednesday, June 23, 2010 08:48 AM

Contract research organizations (CROs) and investigative sites have begun to adopt SAFE-BioPharma digital identities, which are already widely used by biopharmaceutical companies, in order to sign contracts and other clinical trial documents electronically.

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Parexel Hires Former FDA, MHRA Regulators

Tuesday, June 22, 2010 10:01 AM

Parexel Consulting, a business unit of Parexel International, has appointed former regulators Toby Silverman, M.D. and Keith Watson, Ph.D. as principal consultants.

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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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Clinical Trial Activity in Russia Dipped in 2009

Friday, March 5, 2010 06:56 AM

According to Russia-based contract research organization (CRO) Synergy Research Group’s Annual Orange Report, Russia’s regulatory agency Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (RosZdravNadzor, RZN) approved 577 new clinical trials during 2009, 6% fewer than in 2008. Sixty percent, or 348 of the new studies, were multinational multi-center trials, down 4% from 2008.

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Clinilabs Launches New Document Management System

Thursday, February 4, 2010 07:02 AM

New York-based contract research organization (CRO) Clinilabs released its own document management system that the company said will significantly reduce the cost of information management and clinical monitoring and auditing during clinical trials.

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FDA Issues Draft Guidance for IRBs Conducting Continuing Review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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InVentiv Expands REMS Business with ParagonRx Acquisition

Thursday, January 7, 2010 09:09 AM

Banking on the growing demand for risk evaluation and mitigation strategy services (REMS), New Jersey-based inVentiv Health acquired REMS consulting company ParagonRx for an undisclosed sum in a deal that was finalized December 31.

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Guest Commentary: SaaS and Pharmacovigilance—A Vital Partnership

Wednesday, December 23, 2009 07:36 AM

Michael Reynolds, APCER Pharma

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