Theorem Clinical Research

Europe

BIA says E.U. Clinical Trial Regulation misses goal to make E.U. more attractive for trial conduct

Thursday, January 2, 2014 10:28 AM

The endorsement by the E.U. Committee of Permanent Representatives of the political agreement reached by the Lithuanian E.U. Council Presidency and the European Parliament, on the compromise text of the proposed E.U. Clinical Trials Regulation looks set to not deliver on the initial goal set by the European Commission (E.C.) when it launched the process in July 2012 of making the E.U. a more attractive location to conduct clinical trials.

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EFPIA, PhRMA trial data sharing plan goes into effect

Thursday, January 2, 2014 10:22 AM

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have implemented the joint Principles for Responsible Clinical Trial Data Sharing.

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NIHR researchers awarded $1M to search for Parkinson’s biomarkers

Friday, December 13, 2013 01:53 PM

Researchers from the National Institute for Health Research (NIHR) have secured a $1 million grant from research charity Parkinson's U.K. to search for elusive Parkinson's biomarkers. People with Parkinson's have an increased risk of approximately 80% to develop dementia.

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Venn Life Sciences acquires Medevol

Wednesday, December 11, 2013 11:23 AM

European CRO Venn Life Sciences has acquired Medevol, a CRO based in Northern Ireland, for a total maximum consideration of $1.1 million.

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Centro Ricerche Cliniche di Verona receives new EUCROF early phase quality mark

Wednesday, December 11, 2013 11:17 AM

Centro Ricerche Cliniche di Verona (CRC), an early phase CRO, has become the first organization to be accredited under a new scheme of quality certification conducted by the European CROs Federation (EUCROF).

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Johnson & Johnson Innovation establishes network of partnering offices

Monday, December 9, 2013 12:29 PM

Johnson & Johnson Innovation, London, has formed a network of partnering offices across U.K. life science clusters. The offices function as extensions of its London Innovation Center, to work with academics and entrepreneurs throughout the U.K. to identify early stage innovation and support the translation of research into new products for patients.

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NIHR Clinical Research Network improves non-commercial study inclusion times

Monday, December 9, 2013 12:22 PM

The National Institute for Health Research (NIHR) Clinical Research Network has decreased the time it takes for studies funded by non-commercial organizations, such as charitable organizations and academic institutions, to be included in the NIHR Portfolio of research.

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Almirall reorganizes in Europe, cuts 250 positions

Friday, December 6, 2013 12:57 PM

Pharmaceutical company Almirall has reorganized in Europe to optimize its portfolio potential. Pharmaceutical markets in Europe, particularly in Spain, have been affected in recent years by economically driven decisions made by various countries’ health authorities that have negatively affected the growth of those markets and the introduction and uptake of new products. 

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New Scientific Panel for Health to be established under Horizon 2020

Wednesday, December 4, 2013 01:04 PM

The Alliance for Biomedical Research in Europe (Biomed Alliance), a consortium of 21 member organizations representing over 400,000 experts, welcomes the E.U.’s decision to create a Strategic Scientific Panel for Health within H2020 as a major step toward more targeted investment in health innovation in Europe. The panel was voted in by the European Parliament in Strasbourg after lengthy negotiations on the overall H2020 proposal, which will run from 2014 to 2020.

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Industry responds to European clinical trials regulation revision

Monday, December 2, 2013 01:09 PM

There is an increasing international competition in clinical trials because clinical research creates jobs, drives academic excellence and delivers innovative medicines for patients. Improving the attractiveness and competitiveness of Europe as a prime location for clinical research was a key driver for the revision of the E.U. clinical trial legislation, which aimed to reduce unnecessary red tape whilst preserving the quality and safety of clinical trials.

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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

From the trenches: Sites' eye view of state of the industry
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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