AiCure

Ethics/Regulatory

EMA now accepting Safe-BioPharma digital signatures on eSubmissions

Friday, September 6, 2013 02:53 PM

Beginning this month, SAFE-BioPharma digital signatures will be accepted by the European Medicines Agency (EMA).  

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John Hopkins study suggests neurologists unaware of drug risks

Friday, August 16, 2013 10:41 AM

A study by Johns Hopkins researchers shows a fifth of U.S. neurologists appear unaware of serious drug safety risks associated with various anti-epilepsy drugs, potentially jeopardizing the health of patients who could be just as effectively treated with safer alternative medications.

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Industry associations support FDA Safety Over Sequestration Act

Wednesday, August 7, 2013 11:45 AM

Senator Mark Pryor, chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, and Sens. Roy Blunt, Daniel Coats, Al Franken and Jerry Moran last week introduced S. 1413 to exempt future FDA user fees from sequestration. A similar bill, H.R. 2725, was introduced in the U.S. House of Representatives earlier this month by Representatives Leonard Lance, Anna Eshoo, Mike Rogers and Doris Matsui.

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PhRMA endorses FDA Safety Over Sequestration Act

Monday, July 29, 2013 11:28 AM

The Pharmaceutical Research and Manufacturers of America (PhRMA) has endorsed the FDA Safety Over Sequestration Act of 2013. PhRMA represents U.S. biopharmaceutical research and biotechnology companies devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives.

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EFPIA, PhRMA release joint principles for responsible data sharing

Wednesday, July 24, 2013 01:41 PM

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have endorsed joint “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”

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Kantara Initiative, SAFE-Biopharma support NSTIC principles

Wednesday, July 3, 2013 10:41 AM

The Kantara Initiative, which helps organizations establish verified trust in use of digital identities for business and government services, and SAFE-Biopharma, which provides a global digital identity and digital signature standard for the life sciences, have pledged to adopt the four principles of the National Strategy for Trusted Identities in Cyberspace (NSTIC), the White House initiative to improve the privacy, security and convenience of sensitive online transactions.

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WIRB-Copernicus Group, UL Quality, Compliance and Learning partner

Friday, June 28, 2013 01:50 PM

The WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for human research, has partnered with UL Quality, Compliance and Learning (formerly EduNeering), a technology-driven compliance learning solutions company, to bring educational opportunities to clinical research professionals.

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AAHRPP, ViS Research Institute collaborate

Wednesday, June 26, 2013 02:51 PM

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) and the ViS Research Institute have allied to protect research participants by providing easy access to information on the quality and standards of organizations that conduct clinical trials.

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Parliament committee adopts amendments to proposed clinical trial regulation

Monday, June 3, 2013 11:35 AM

The European Parliament’s Committee on Environment and Public Health has unanimously adopted reporter Glenis Willmott’s amendments to the Commission’s proposed regulation on clinical trials, including provisions requiring sponsors to publish full clinical study reports once a marketing authorization decision has been taken.

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FDA lifts clinical hold on anthrax vaccine program

Thursday, May 30, 2013 03:24 PM

PharmAthene, a biodefense company developing medical countermeasures against biological and chemical threats, said the FDA has lifted the clinical hold previously placed on a proposed phase II study of SparVax, a next generation recombinant anthrax vaccine.

"Anthrax has been identified as one of the foremost potential biological threats to the nation,” said Eric I. Richman, president and CEO.  “The U.S. government's requirement for a recombinant anthrax vaccine for the civilian Strategic National Stockpile is an important national security imperative that remains unfilled. Next-generation anthrax vaccines like SparVax, which employ modern vaccine technology, offer the potential for improved convenience, cost-effectiveness, more rapid immunity, and the ability for large scale rapid delivery.”

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CWWeekly

November 24

Tufts CSDD’s $2.6 billion price tag to develop and bring a new drug to market raises questions, criticisms

Medidata joins GlaxoSmithKline in study to evaluate the impact of wearing mobile devices in clinical trials

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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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