Theorem Clinical Research


GVB BIO licenses biomarker database to FDA

Thursday, February 7, 2013 08:00 AM

GVK Biosciences, a discovery, research and development organization providing a broad spectrum of services, is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the FDA. The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the FDA in its Biomarker Qualification Process.

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Almac’s new U.S. commercial packaging operations pass FDA inspection

Wednesday, February 6, 2013 09:16 AM

Global service provider Almac has passed FDA inspection of its new U.S. commercial packaging operations located in Audubon, Penn. The inspection took place on Jan. 9 and 10, 2013, from which the regulatory body concluded that the site is fully compliant with Good Manufacturing Practices, with no 483 issued.

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European Medicines Agency to focus on efficiency, transparency in 2013

Thursday, January 10, 2013 02:21 PM

The European Medicines Agency’s management board has adopted the agency’s work program and budget for 2013, with priorities continuing to be ensuring assessment activities are conducted to the highest scientific levels, increasing efficiency in its activities and developing initiatives for greater transparency and communication with stakeholders.

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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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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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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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September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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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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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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