Study Conduct

Clinilabs Partners with Renal Research Institute

Wednesday, February 10, 2010 07:12 AM

New York-based contract research organization (CRO) Clinilabs recently announced a collaboration with the Renal Research Institute (also headquartered in New York) to conduct studies in patients with renal impairment.

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Palm Beach Research Benefits from Close of Radiant West Palm Beach

Monday, February 8, 2010 07:01 AM

One investigative site’s bad fortune will become another site’s good as site management organization (SMO) Radiant Research closes its West Palm Beach, Fla., site, and Palm Beach Research Center takes on that site’s lead investigator along with an ongoing trial.

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Accurate Clinical Research Adds Second Location

Monday, January 25, 2010 12:09 PM

Houston, Texas-based Accurate Clinical Research (ACR), a self-described clinical coordinating center, has added a second location on Nassau Bay in Houston, where their new partnering physician has both his clinical practice and research practice.

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Charges Filed in Case of Fabricated Study Results

Thursday, January 21, 2010 07:15 AM

Charges were filed in the case of Scott Reuben, the U.S. anesthesiologist who allegedly fabricated clinical trial data for at least 21 published articles. Reuben, who wrote about pain management after surgery, was formerly chief of acute pain at Bay State Hospital in Springfield, Mass.

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AAHRPP Changes Process, Awards Fewer Accreditations

Monday, December 28, 2009 08:30 AM

Organizations accredited by the Accreditation of Human Research Protection Programs (AAHRPP) will soon be able to go longer between accreditation renewals as part of a number of process changes effective January 1.  

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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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IQWiG Calls for Mandatory Clinical Trial Transparency in EU

Tuesday, December 8, 2009 01:06 PM

The Institute for Quality and Efficiency in Health Care (IQWiG) is calling on the German government to push for an EU regulation making it mandatory for sponsors to register and publish the results of all of their clinical trials, including negative ones. 

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University of Rochester Medical Center Creates Cardiac Safety Center

Wednesday, November 25, 2009 07:34 AM

The University of Rochester Medical Center announced the creation of a new center that will assist researchers studying the electrical activity of the heart with the goal of improving drug safety, understanding cardiac arrhythmias and developing new electrocardiograph technologies.

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

Thursday, November 19, 2009 08:28 AM

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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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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