FDA

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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United BioSource Continues to Grow with Purchase of Gigamoto Technology

Wednesday, September 23, 2009 06:28 AM

United BioSource Corporation (UBC) completed its second acquisition in two weeks with the purchase of Gigamoto Technology Partners, a Pennsylvania-based software company specializing in drug safety and risk management, for an undisclosed sum.

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FDA Launching New Rules to Expand Access to Investigational Drugs

Thursday, August 27, 2009 09:16 AM

The U.S. Food and Drug Administration published two new rules to help seriously ill people gain access to investigational drugs when they are not eligible for clinical trials and have exhausted other treatment options.

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ACRO: Global Clinical Trials Benefit Drug Development

Tuesday, July 28, 2009 07:14 AM

A new report released last week by the Association of Clinical Research Organizations (ACRO) says clinical trials conducted in the developing world not only match the quality and safety standards of those conducted in the developed world but they also improve the global drug development process.

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FDA Debars Two Clinical Investigators Six Years after Fraud Convictions

Wednesday, July 15, 2009 07:27 AM

More than six years after being convicted of fraud, two medical researchers were recently barred from working as clinical investigators by the U.S. Food and Drug Administration (FDA).

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CenterWatch Monthly June 2009

Friday, June 5, 2009 09:17 AM

U.S. Sites Rate Medpace, Kendle, ICON as Top CROs in 2009

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