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FDA takes steps to strengthen cybersecurity of medical devices

Friday, October 3, 2014 11:01 AM

To strengthen the safety of medical devices, the FDA has finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

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Parexel International acquires ClinIntel

Friday, October 3, 2014 10:58 AM

Global CRO Parexel International, headquartered in Waltham, Mass., has acquired privately-owned ClinIntel, a provider of clinical Randomization and Trial Supply Management (RTSM) services, based in Crawley, U.K.

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EMA to publish clinical reports effective January 2015

Friday, October 3, 2014 10:57 AM

The EMA has decided to publish clinical reports that underpin the decision-making on medicines. Following extensive consultations held by the agency with patients, healthcare professionals, academia, industry and other European entities over the past 18 months, the EMA management board unanimously adopted the new policy Oct. 2. It will apply to clinical reports contained in all applications for centralized marketing authorizations submitted after that date. The reports will be released as soon as a decision on the application has been taken. The policy will enter into force in January 2015.

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Salix Pharmaceuticals, Cosmo Technologies terminate merger agreement

Friday, October 3, 2014 10:50 AM

Salix Pharmaceuticals, based in Raleigh, N.C., and Lainate, Italy-based Cosmo Pharmaceuticals have agreed to terminate their previously-announced merger agreement pursuant to which Salix would have combined with, and become a wholly-owned subsidiary of, Cosmo Technologies, a subsidiary of Cosmo Pharmaceuticals. Effective immediately, Salix will make a $25 million payment to Cosmo.

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WIRB-Copernicus Group appoints Lindsay McNair chief medical officer

Friday, October 3, 2014 08:29 AM

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services and software to support clinical research, has promoted Lindsay McNair, M.D., M.P.H., M.S.B., to chief medical officer.

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CluePoints’ statistical monitoring used in phase III gastric cancer trial

Thursday, October 2, 2014 02:30 PM

CluePoints, a Cambridge, Mass.-based provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that its CSM platform has been used to assess the quality and integrity of data in a phase III study of gastric cancer.

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Guideline outlines applications for pediatric investigation plans

Thursday, October 2, 2014 02:29 PM

The European Commission (E.C.) has published a revised guideline on applications for pediatric investigation plans, or PIPs, in the Official Journal of the European Union. The new guideline is expected to facilitate the application process. It is intended for all medicines developers.

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Report: Small and medium-sized enterprises are driving innovation in medicines

Thursday, October 2, 2014 02:28 PM

Micro, small and medium-sized enterprises (SMEs) are a motor of innovation in the European Union (E.U.). Between 2010 and 2012, more than one in four new innovative medicines recommended for marketing authorization in the E.U. originated from SMEs, as shown in an analysis published by the EMA in January. 

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Rare Cancers Europe calls for new criteria to be used in clinical trials

Thursday, October 2, 2014 02:26 PM

A consensus paper by Rare Cancers Europe (RCE) calls for new methodologies to be applied to clinical studies in rare cancers. RCE—a multi-stakeholder initiative representing patient associations, medical societies and industry—is calling both the community of researchers and European authorities to address research methodologies and regulatory criteria that could limit rare cancer patient access to new therapies. This would mean discrimination against this patient population.

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With NIH Grant, Cedars-Sinai brings big data to neuro disease research

Thursday, October 2, 2014 02:23 PM

Investigators at the Los Angeles Cedars-Sinai Regenerative Medicine Institute have received a grant from the NIH to participate in a consortium taking the study of motor neuron disorders—such as Lou Gehrig's disease and spinal muscular atrophy—to a new, comprehensive perspective.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

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CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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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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