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Study Conduct

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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CRF Health eCOA webinar series

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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Novartis, Janssen, Eli Lilly, Aptiv Solutions co-found new consortium

Friday, February 21, 2014 11:05 AM

Aptiv Solutions, a global biopharmaceutical and medical device development services company, Novartis Pharma, Janssen Pharmaceuticals and Eli Lilly have joined in co-founding the ADDPLAN DF Consortium. The members of the consortium are collaboratively developing new statistical methodologies for the design of innovative dose-finding clinical trials, with an emphasis on adaptive designs. The ADDPLAN DF Consortium also will focus on enhancing the trial execution technologies required to handle the multiple adaptations integral to complex adaptive dose-finding trials. Aptiv Solutions will integrate and validate the methodologies that emerge from the ADDPLAN DF Consortium into its ADDPLAN DF software for the design, planning and analysis of dose finding trials, in addition to ensuring that these designs can be easily implemented through its proprietary execution platform.

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NHS England responds to concerns about information sharing

Wednesday, February 19, 2014 01:11 PM

Tim Kelsey, national director for patients and information for NHS England, has issued a statement in response to concerns about information sharing, saying, In recent weeks, we have heard from patients, many GPs, their professional organizations and groups like Healthwatch. They have told us very clearly that patients need more time to learn about information sharing, the benefits and their right to object.”

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Sir Stuart Rose to advise on NHS leadership

Friday, February 14, 2014 01:49 PM

Sir Stuart Rose, a highly-regarded business leader in Britain who turned around the fortunes of Marks and Spencer, will advise how the NHS can attract and retain the very best leaders to help transform the culture in under-performing hospitals.

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Drugs.com, TrialReach to give patients access to drugs in development

Thursday, February 13, 2014 02:48 PM

Drugs.com, an online clinical drug resource, and TrialReachare partnering to provide patients with information and access to treatments that are still under development. The new partnership will bring TrialReach's patient-centric content and tools directly to the 25 million people who visit Drugs.com every month.

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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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The CenterWatch Monthly

March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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