Theorem Clinical Research

Europe

Proposed health IT strategy aims to promote innovation, protect patients, avoid duplication

Friday, April 4, 2014 12:05 PM

HHS has released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.

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New structure for NIHR Clinical Research Network

Thursday, April 3, 2014 11:06 AM

The National Institute for Health Research (NIHR) Clinical Research Network, which provides more than $471.4 million a year to support the delivery of clinical research studies in the NHS, has reconfigured and will be operating in a new streamlined structure.

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Health Research Authority business plan approved to streamline research in U.K.

Wednesday, April 2, 2014 01:44 PM

The U.K. Department of Health has approved the Health Research Authority (HRA) funding plans for HRA Assessment and Approval. This funding means the HRA will be able to reduce duplication and bureaucracy by incorporating assessments by NHS staff alongside the independent Research Ethics Committee opinion, which will result in one application, one assessment and one approval for research in the NHS in England.

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NICE seeks views on how it assesses drugs and other technologies for the NHS

Friday, March 28, 2014 03:15 PM

The National Institute for Health and Care Excellence (NICE) has begun a formal consultation on proposed changes to the way it makes recommendations on new medicines and other treatments for use in the NHS. NICE assesses the clinical and cost effectiveness of new technologies to help ensure patients have access to effective treatments and the NHS makes the best use of its resources.

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Onkodatamed joins Medis

Thursday, March 20, 2014 02:36 PM

Berlin-based clinical research alliance, Medis Research Group, has added Berlin-Brandenburg-based Onkodatamed to its portfolio. Medis Research Group, founded in November, previously consisting only of its two founding members, Allied Clinical Management and ICRC-Weyer, both Berlin-based CROs. The group was formed to better meet requirements of clinical trial sponsors for one-stop shop solutions, hence enabling the two CROs to combine clinical research experience and provide complete service solutions across all stages of the clinical development process.

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Industry reacts to U.K. budget announcement

Thursday, March 20, 2014 01:05 PM

Positive and negative industry responses have surfaced regarding Chancellor George Osborne's budget, from the Ethical Medicines Industry Group (EMIG), the BioIndustry Association (BIA) and the Royal College of General Practitioners (RCGP). The budget includes a $90.9 million establishment of a large-scale cell therapy manufacturing center, an increase in the R&D Tax Credit from 11% to 14.5%, and $175.1 million over five years for doctoral training centers.

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European Medicines Agency launches adaptive licensing pilot project

Thursday, March 20, 2014 01:03 PM

The EMA is inviting companies to participate in its adaptive licensing pilot project. Interested companies should submit ongoing medicine development programs for consideration as prospective pilot cases.

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Teva, NIHR form health research collaboration

Wednesday, March 19, 2014 12:50 PM

Israeli pharmaceutical company Teva will invest $20 million into U.K. clinical trials and $1 million into U.K. dementia research. Teva said it will benefit from the NIHR's translational research infrastructure and its ability to efficiently set up and deliver world-leading health research studies.

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U.K. forms early access to medicines scheme

Monday, March 17, 2014 01:41 PM

The U.K. government has announced a new scheme that aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization.

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New IMI project to incorporate real-life data into drug development

Thursday, March 13, 2014 12:54 PM

The Innovative Medicines Initiative (IMI) has launched a new project called GETREAL that will investigate new ways to integrate data from real-life settings, such as clinics, into drug development in Europe. This will assist healthcare decision makers in choosing how best to grant patients access to a new treatment and help pharmaceutical companies make better decisions during drug development.

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October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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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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