Articles Published in 2007

AstraZeneca to Work with Keio University in Japan

Wednesday, October 3, 2007 11:08 AM

AstraZeneca’s Japanese subsidiary, AstraZeneca KK, signed a Master Clinical Study Agreement with Keio University School of Medicine based in Tokyo. The university reported that due to Japan’s slow pace of drug research, it has taken steps to build up its own clinical trial capabilities and improve the efficiency of its research.

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WIRB Copernicus Group

PRA Moves Headquarters To North Carolina

Monday, October 1, 2007 07:23 AM

PRA International plans to relocate its corporate headquarters from Reston, Va., to Raleigh, N.C. by the end of 2007. The move is to facilitate the CRO’s plans to grow the business. Presently only 37 employees are expected to be affected.

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HHS Report Criticizes FDA’s Human Subject Protection Efforts and Lack of Site Audits

Friday, September 28, 2007 02:32 PM

The U.S. Food and Drug Administration (FDA) audited fewer than 1% of investigative sites, the inspector general of the Department of Health and Human Services (HHS), Daniel R. Levinson, found in a report released Friday.

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Top Stories for the Week of Sept. 24th 2007

Friday, September 28, 2007 11:55 AM

Top News

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Promising Results Seen in Lung Cancer Trials

Wednesday, September 26, 2007 03:20 PM

Merck KGaA reported positive long-term results from a phase II trial of Stimuvax for the treatment of non-small cell lung cancer (NSCLC). The drug is a MUC-1 peptide-based liposomal vaccine, for the potential  treatment of cancers.

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Congress Passes Long Awaited PDUFA Renewal Act

Monday, September 24, 2007 11:27 AM

The U.S. House and Senate passed the long awaited FDA Revitalization Act, a five-year renewal of the Prescription Drug User Fee Act of 1992 (PDUFA). PDUFA allows the FDA to collect fees from drug and device companies applying for regulatory approval. That law was set to expire on Sept. 30.

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Top Stories for the Week of Sept. 17th 2007

Friday, September 21, 2007 07:53 AM

Top News

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Synergy Creates Alliance With Indian CRO Neeman Medical

Tuesday, September 18, 2007 06:40 AM

Russian CRO Synergy Research Group (SynRG) has made its next move to create a global CRO alliance, forming a partnership with Neeman Medical International, an India-based CRO. The alliance will focus on providing international sponsors with monitoring and site and data management services. Neeman Medical was founded in 2001 and is headquartered in New Delhi.

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CenterWatch Monthly: September 2007 Issue

Monday, September 17, 2007 11:36 AM

Fraudulent Study Broker At-Large: Cherie Thibodeau

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ARISE Trials Shows Promising Results for Diabetes

Monday, September 17, 2007 07:41 AM

Atherogenics reported positive results from a phase III trial of succinobucol (AGI-1067), an antioxidant oral vascular cell adhesion molecule-1 (VCAM-1) gene expression inhibitor, for the treatment of diabetes and coronary heart disease. This trial, dubbed ARISE (Aggressive Reduction of Inflammation Stops Events), enrolled over 6,000 subjects internationally. Results were reported at the European Society of Cardiology Congress 2007.

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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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