Theorem Clinical Research

Study Conduct

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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European Healthcare calls for balanced, transparent funding of pharmacovigilance system

Monday, February 24, 2014 10:06 AM

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic medicines Association (EGA), the European biotech industry (EuropaBio), the Association of the European Self-Medication Industry (AESGP) and the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) support the implementation of an effective pharmacovigilance system to ensure patient safety and recognize recent efforts which have been made to ensure greater fairness, proportionality and transparency in some aspects of the proposals for the mechanism of fees to be paid to the EMA for these pharmacovigilance activities. Notably the industry welcomes the improvements regarding the annual fee to be paid by the Marketing Authorization Holders to the EMA. 

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ACRO testifies on effects of India industrial policies on economy

Friday, February 21, 2014 01:45 PM

Members of the Association of Clinical Research Organizations (ACRO) have seen their clinical trials activity in India decrease more than 60% since 2010 as a result of a “confusing, inconsistent and arbitrary” regulatory environment, ACRO’s vice president of Public Affairs, John Lewis, testified before the U.S. International Trade Commission. The USITC hearing was held last week in Washington, DC.

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

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Benefits outweigh the complexities, challenges of finding right vendors

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