Study Conduct

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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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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CenterWatch
CWWeekly

January 19

Roche takes $1B majority stake in Foundation Medicine to use genomic testing to personalize oncology treatments

BRANY launches software, iPad app to streamline protocol creation for investigator-initiated trials

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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