Ethics/Regulatory

CenterWatch Monthly December 2008

Friday, December 5, 2008 11:15 AM

Demand for Medical Writing Continues to Rise

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SFDA, Big Pharma Share Concerns at Shanghai Conference

Monday, November 24, 2008 09:00 AM

In his regulatory keynote address at the China Trials 2008 conference in Shanghai, Dr. Yi Feng, director, Office of Review Management, Center for Drug Evaluation (CDE), State Food and Drug Administration (SFDA) gave a broad overview of the evolution of global clinical trials in China and pinpointed future trends and goals in the country.

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DIA Opens Beijing Office

Wednesday, November 19, 2008 11:13 AM

The Drug Information Association (DIA) has expanded its worldwide operations by opening an office in Beijing, China. Headquartered in Horsham, Pa., DIA has regional offices in Switzerland, Japan, and now China.

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C-TASC to Help FDA Improve NDA Review Process

Thursday, October 16, 2008 12:00 PM

Clinical Trials & Surveys Corp (C-TASC), a clinical trials solutions company, will assist the U.S.Food and Drug Administration (FDA) Centers for Quality Assurance and Biostatistics to develop new methods and procedures for evaluating all New Drug Applications submitted for FDA approval. Under the $5.5 million base contract, C-TASC will use components of its StudyCTMS study management software application to customize a solution for the FDA that will standardize how clinical trial data for new therapies will be presented and reviewed. C-TASC statisticians will also work with FDA staff to perform some of the data preparations and analyses for these reviews. StudyCTMS is C-TASC’s proprietary web-based data management solution that enables clinical trials managers to easily develop and manage clinical studies and deliver the accumulated data and metadata in an easy-to-read and FDA-acceptable format.

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Conflict of Interest Case Could Change Disclosure Rules

Tuesday, October 14, 2008 06:37 AM

The congressional investigation into an influential psychiatrist’s failure to disclose more than a million dollars in drugmaker payments is the latest in a spate of conflict-of-interest investigations that may force changes in the way financial disclosures are handled.

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ethica expands IRB services to Latin America

Monday, October 6, 2008 11:00 AM

ethica Clinical Research, a Montreal, Canada-based contract research organization (CRO), has partnered with Argentina-based Blanchard y Asociados to provide ethics review services for clinical trials in Latin America.

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CenterWatch Monthly October 2008

Friday, October 3, 2008 02:44 PM

Trio of Companies in Strategic Outsourcing Partnerships with Lilly

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AAHRPP Accredits First Independent Investigative Site

Monday, September 29, 2008 01:00 PM

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited HOPE Research Institute of Arizona as the first-ever independent investigative research facility to attain AAHRPP’s approval.

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Stay Granted in Muscular Dystrophy Clinical Trial Case

Friday, September 19, 2008 12:38 PM

The U.S. Court of Appeals for the Third Circuit has granted PTC Therapeutics’ request for a stay of the Federal District Court’s decision on August 20 that would have forced the biotech company to provide its experimental drug PTC124 to 16-year-old Duchenne muscular dystrophy patient Jacob Gunvalson outside its clinical trial process.

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Report Questions Safety, Ethics of Clinical Trials in India

Tuesday, September 2, 2008 09:00 AM

India’s booming clinical trials business is under scrutiny, following a story in a UK newspaper that set off a flurry of media and regulatory attention.

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