Study Conduct

Harrington Discovery Institute opens annual grant competition

Wednesday, March 19, 2014 12:57 PM

The Harrington Discovery Institute (HDI) at University Hospitals (UH) Case Medical Center has opened its third annual grant competition to fund and support physician-scientists at major academic medical centers across the nation in their efforts to accelerate promising drug discoveries.

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WIRB Copernicus Group

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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PhRMA launches national campaign to increase diversity in clinical trials

Thursday, March 13, 2014 12:55 PM

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum have announced a first-of-its-kind national campaign to help increase diversity in clinical trials.

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EFPIA responds to new Clinical Trials regulation

Wednesday, March 12, 2014 02:23 PM

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the political agreement reached by the European co-­legislators, with the aim of a rapid adoption of the new Regulation on Clinical Trials. However, the original objectives of this legislation should be remembered: to enhance efficiency in the clinical trials regulation process and, in turn, to boost the European Union's competitiveness as a place to conduct research and make for more efficient patients access to new innovative treatments. EFPIA believes some of the initial objectives of the legislation have been only partially achieved; therefore, the success of this legislation strongly depends on how it will apply in practice.  

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Report: Healthcare workers express satisfaction and confidence in profession

Friday, March 7, 2014 01:13 PM

Medical Staffing Network Healthcare’s (MSN) 2014 Pulse of the Healthcare Industry infographic, a graphical representation of the employment outlook, regulatory impact and overall industry perspectives of healthcare professionals across the country, reveals a healthcare workforce that is stable and secure in their current roles, satisfied and confident in their careers, yet largely uncertain of the potential impact of healthcare reform on the profession.

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ACRES launches Global Stakeholder Consultation with ViS, Essex Management

Friday, March 7, 2014 01:05 PM

The Alliance for Clinical Research Excellence and Safety (ACRES), a nonprofit multi-stakeholder collaborative building a shared global system to more effectively deliver promising new therapeutics, has launched a Global Stakeholder Consultation to better inform the development of standards, processes and policies to promote excellence and sustainability of clinical research sites worldwide.

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Schulman Associates IRB, Falcon Consulting Group form joint venture

Monday, March 3, 2014 12:29 PM

Schulman Associates IRB and Falcon Consulting Group, a provider of Clinical Quality Assurance (CQA) and Good Clinical Practice (GCP) services, have formed a joint venture—Provision Research Compliance Services.

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BBK Worldwide launches Bio Notifier Plus

Friday, February 28, 2014 11:57 AM

BBK Worldwide, a provider of patient recruitment, has launched BIO Notifier Plus, which utilizes a global opt-in physician database, a proprietary rating and ranking system and in-country direct physician contact to bring specialists to clinical trials.

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Novartis expands clinical trial data transparency

Thursday, February 27, 2014 12:31 PM

Novartis has announced additional steps to extend its presence in clinical trial data transparency. Since 2005, and before requirements were in place, Novartis has been voluntarily disclosing summaries of Clinical Study Reports of its innovative medicines on its own web site (www.novctrd.com). In addition, the company is committed to enhancing Clinical Study Report summaries for all new pivotal studies to include easy to understand consumer language summaries and additional interpretation of data as of the end of 2014.

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CEOi, NY Academy of Sciences to launch Global Alzheimer's Platform

Wednesday, February 26, 2014 01:21 PM

The Global CEO Initiative (CEOi) on Alzheimer's Disease and the New York Academy of Sciences have convened representatives from industry, academia, government and nonprofits to launch the development of a Global Alzheimer's Platform (GAP), designed to reduce the time and costs of Alzheimer's clinical trials, develop an infrastructure that promotes innovation and assure international collaboration.

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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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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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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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