FDA

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FDA Issues Draft Guidance for IRBs Conducting Continuing Review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The U.S. Food and Drug Administration (FDA) recently released draft guidance for institutional review board (IRB) continuing review—the first updates that the regulatory agency has provided for this process since it issued IRB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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Prometrika and Boston Biotech Clinical Research Help Sponsors Create DMCs

Tuesday, December 15, 2009 09:39 AM

Contract research organization (CRO) Prometrika and medical research consulting firm Boston Biotech Clinical Research (BBCR) are teaming up to provide data monitoring committee (DMC) services to clinical trial sponsors.  Together, the companies will help sponsors establish and operate independent DMCs (also called data safety monitoring boards and data and safety monitoring committees).

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ICON Receives FDA Warning Letter

Wednesday, December 9, 2009 07:01 AM

Dublin contract research organization (CRO) ICON received a warning
letter from the U.S. Food and Drug Administration (FDA) related to the
management of two clinical studies conducted between 2004 and 2006.

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China Drug Agency Details Process Changes at ChinaTrials 2009

Tuesday, November 10, 2009 06:26 AM

At the ChinaTrials 2009 conference in Beijing Monday, Dr. Yi Feng, director of Review Management, Center for Drug Evaluation (CDE) in China, laid out plans to implement a new GRP process. GRP is an acronym representing three “R” practices: Good Review Practice, Good Regulatory Practice and Good Registration Practice. It is expected that implementing GRP will greatly contribute to shortening drug review timelines in China. 

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Phase Forward Provides Free Download for CDISC Adopters

Thursday, October 29, 2009 09:04 AM

Phase Forward, a provider of data management solutions for clinical trials and drug safety, released its DefineValidator tool, Release 1.0, as a free download for Clinical Data Interchange Standards Consortium (CDISC) adopters.

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UBC Gets Big Boost with $125 Million Growth Equity Investment

Thursday, October 8, 2009 12:52 PM

Maryland-based contract research organization (CRO) United BioSource Corporation (UBC) received a $125-million growth equity from Berkshire Partners LLC, a Boston-based private equity firm, to support the company’s evidence-based acquisition and service offering expansion strategy. 

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