Study Conduct

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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WIRB Copernicus Group

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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CRF Health eCOA webinar series

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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Parexel rebrands technology subsidiary as Parexel Informatics

Thursday, February 13, 2014 02:06 PM

Global CRO Parexel International has rebranded its Perceptive Informatics subsidiary, which provides the Perceptive MyTrials eClinical platform and other advanced clinical development technology solutions, as Parexel Informatics.

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GSK, Uppsala launch $140.6M European program targeting novel antibiotics

Wednesday, February 12, 2014 01:20 PM

Over 30 European universities, research institutes and companies, led by GlaxoSmithKline and Uppsala University, are joining forces in a six-year program supported by the Innovative Medicines Initiative (IMI) to develop novel antibiotics against Gram-negative pathogens in a project called ENABLE (European Gram-Negative Antibacterial Engine), including open calls for candidates outside the consortium.

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Ulster launches a clinical research network for mental health

Thursday, February 6, 2014 11:47 AM

The University of Ulsterhas launched a dedicated Clinical Research Network for Northern Ireland. The new network means that mental health patients from Northern Ireland can now be involved in major national and international research trials. It also will ensure researchers and health professionals have a better understanding of mental health services.  

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Boston Children's Hospital partners on pharmacogenomics study in pediatric population

Wednesday, February 5, 2014 01:36 PM

Aiming to reduce adverse drug reactions—which affect some 70,000 children annually in the U.S.—a study at Boston Children's Hospital, in partnership with the Medical College of Wisconsin(MCW) and the Children's Hospital of Wisconsin Research Institute, is using genetic information to predict children's reactions to medications, ultimately enabling clinicians to select a more individualized therapy for the patient.

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