Theorem Clinical Research

Europe

European researchers to submit proposals focused on curing virological diseases

Tuesday, April 8, 2014 02:41 PM

In a quest to cure chronic virological diseases such as HIV, hepatitis B and hepatitis C, Bristol-Myers Squibb has asked European researchers—notably junior faculty and young investigators—to submit innovative research ideas  to accelerate novel solutions as part of its Partnering for Cure program.

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Europe approves clinical trial transparency law

Monday, April 7, 2014 12:39 PM

Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with E.U. ministers and passed by Parliament. The law also facilitates cross-border cooperation to make clinical trials larger, more viable and more reliable, which should in turn boost efforts to develop special treatments (e.g. for rare diseases).

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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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September 29

WCG sees ePharmaSolutions’ clinical trial portal as the next step in the data evolution, company mission

Cutting-edge advertising can ‘break through the clutter’ for successful patient recruitment

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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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