CenterWatch Monthly December 2009

Wednesday, December 2, 2009

Maine Revises Clinical Trial Transparency Rule

The revised regulations, which went into effect Nov. 2, are an attempt to clarify the Maine’s requirements for clinical trial registration and results reporting and to make them more compatible with federal reporting requirements under the FDA Amendments Act of 2007, which called for a federal system that expands public access to data from clinical trials.

FDA, OHRP Guidance on Unanticipated Problems and Serious Adverse Events

FDA and HHS regulations require that unanticipated problems encountered in clinical trials be reported. The FDA regulations require investigators to report unexpected, serious adverse events to the sponsor and the sponsor, in turn, shall report these events to the FDA in an expedited manner.

Debate Intensifies Over Future Shape of Safety Reporting

Europe’s system of safety reporting continues to be plagued by a host of inconsistencies, and no stakeholders appear happy with the current mechanisms for handling suspected unexpected serious adverse reactions (SUSARs).

Eye On: Lymphoma

Lymphoma, a form of blood cancer in which white blood cells known as lymphocytes proliferate more rapidly or have a longer than normal life span, may arise in the lymph nodes, spleen or other organs, bone marrow or  blood.

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i3, Acurian in Patient Recruitment Deal

Tuesday, December 1, 2009

Pharmaceutical services company i3 has entered into an agreement with Acurian, a provider of patient recruitment and retention solutions, to provide study sponsors with a more robust solution to recruit investigators for clinical trials. 

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PPD Continues China Expansion with Deal to Acquire Drug Discovery Company BioDuro

Thursday, November 19, 2009

Less than a month after announcing its acquisition of China-based contract research organization (CRO) Excel PharmaStudies and plans to dominate the Asia-Pacific region,PPD, the Wilmington, N.C.-based global CRO has signed an agreement to acquire BioDuro LLC, a drug discovery outsourcing company. The acquisition of the 660-employee company will expand PPD’s drug development capabilities in China.  

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Whistleblower Suit Filed Against Carle Foundation Hospital, Clinic Over Patient Protection

Thursday, November 19, 2009

Charging that the Carle Foundation Hospital and Carle Clinic failed to protect cancer patients in their clinical trials, Suzanne Stratton, Ph.D, the former vice president for research at the Carle Foundation Hospital in Urbana, Ill., filed a whistleblower lawsuit in federal court against the hospital’s chief executive officer, the Carle Clinic Association, Kendrith Rowland, M.D., a lead physician at the Carle Clinic, and Bruce Wellman, M.D., the Carle Clinic CEO. 

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