NIHR launches new Clinical Trials Toolkit for researchers

Thursday, January 10, 2013 02:09 PM

The National Institute for Health Research (NIHR) has launched a new Clinical Trials (CT) Toolkit web site designed to help researchers navigate through the complex landscape of setting up and managing clinical trials in line with regulatory requirements.

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WIRB Copernicus Group

Mystery shopper campaign highlights NHS shortcomings in promoting clinical research

Thursday, January 10, 2013 02:05 PM

Many British NHS patients are hitting an information "brick wall" when it comes to finding out about clinical research, according to the results of a mystery shopper investigation commissioned by the National Institute for Health Research Clinical Research Network.

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CRF Health eCOA webinar series

FDA, new MDIC to develop regulatory science to speed access to medical devices

Monday, December 3, 2012 11:48 AM

The FDA has become part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment and review of new medical devices.

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EFPIA gives recommendations for clinical trial data transparency

Tuesday, November 27, 2012 02:43 PM

The European Federation of Pharmaceutical Industries and Associations recently held a workshop to give insight into the different views on the sensitive issue of clinical data transparency in Europe.

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FDA issues draft guidance for IRBs

Tuesday, November 27, 2012 11:28 AM

The FDA on Nov. 20 issued a draft guidance titled Draft Guidance for IRBs, Clinical Investigators and Sponsors--IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.

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EMA investigates Roche's alleged non-compliance with pharmacovigilance obligations

Wednesday, October 24, 2012 09:46 AM

The European Medicines Agency (EMA) has initiated an infringement procedure against Roche Registration, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicines.

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Leading researchers outline principles for conduct of comparative effectiveness research

Wednesday, September 12, 2012 11:51 AM

A new set of principles developed by a group of leading researchers could help to ensure more consistency in how comparative effectiveness research (CER) is planned and conducted. These guiding principles were published in the September issue of The Journal of Comparative Effectiveness Research.

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CAP-ASCCP make recommendations to stadardize histopathologic terminology, guide optimal biomarker use

Monday, September 10, 2012 10:17 AM

A working group from the Lower Anogenital Squamous Terminology (LAST) Standardization Project, an interdisciplinary project led by the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP), has published consensus recommendations to standardize the histopathologic terminology for squamous epithelial lesions of the lower anogenital tract associated with human papillomavirus and to guide optimal biomarker use, according to Ventana Medical Systems, a member of the Roche Group.

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New executive committee named to CTTI

Friday, September 7, 2012 02:08 PM

The Clinical Trials Transformation Initiative (CTTI) has named a 14-member executive committee, resetting CTTI’s strategic direction and ensuring that the organization informs and facilitates meaningful improvements to clinical trial design and conduct.

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Expanded IFPMA Code of Practice for pharma industry goes into effect around the world

Tuesday, September 4, 2012 12:44 PM

The International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA) expanded Code of Practice has taken effect around the world. Governing how companies interact with healthcare professionals, medical institutions and patient organizations, this new code has been adopted by all IFPMA member companies and member associations.

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July 21

As job growth in drug development sector soars, more employees are seeking new opportunities

U.K. study: Prisoners should have the right to participatein clinical trials on moral grounds, for healthcare access

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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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CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

Strategies for success evolving in phase I space
Sites see increasing complexity, more patients, greater focus on efficacy

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