• Margaret Hamburg to Resign as FDA Commissioner

    Feb 5, 2015, 10:40 by Michael Croft
    Clinical Informatics News | The White House will announce tomorrow that Margaret Hamburg, Commissioner of the Food and Drug Administration since 2009, is stepping down. Hamburg has led the agency through hugely consequential changes to its powers and regulatory authority over one of the longest terms as commissioner in FDA history.
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  • January Clinical News Briefs

    Feb 3, 2015, 10:40 by Michael Croft
    Clinical Informatics News | News and product releases from around the industry, including new analysis technology for Sequenom's non-invasive prenatal tests and Oracle's automated medication adherence tracker.
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  • A New Initiative on Precision Medicine

    Jan 30, 2015, 00:00 by Michael Croft
    New England Journal of Medicine | Francis Collins and Harold Varmus discuss the President's Personalized Medicine Initiative.
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  • New FDA Powers, Responsibilities in Draft 21st Century Cures Act

    Jan 28, 2015, 12:30 by Michael Croft
    Clinical Informatics News Brief | The House Committee on Commerce and Energy has published a draft version of the 21st Century Cures Act, a sweeping bill containing numerous changes to the FDA's powers to review and approve drugs and medical devices.
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  • Drug Prices Rose Across Classes in 2014

    Jan 28, 2015, 12:00 by Michael Croft
    Clinical Informatics News Brief | This week the Truveris National Drug Index released its first full year figures. In 2014, generic and specialty drugs combined rising 10.9%. Brand drug prices spiked 14.8%, while specialty drug prices jumped 9.7%. Generics, historically intended to curb costs, are contributing to prescription price inflation, increasing 4.9% last year. 
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  • In Defense Department's Health IT Overhaul, a Crossroads for American Healthcare

    Jan 27, 2015, 10:10 by Michael Croft
    Clinical Informatics News | As the Department of Defense considers bids to replace its legacy EHR system with a modernized solution, it stands to create the nation's largest interconnected health IT system. That could have big repercussions for the future of EHR interoperability, population health, and coordinated care in the military and across the country.
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  • Rho Showcases Clinical Services Expertise at OCT West Coast

    Jan 27, 2015, 00:00 by Michael Croft
    CHAPEL HILL, NC, UNITED STATES - Jan 27, 2015 - WHAT:  Rho, a full-service contract research organization (CRO), will highlight its continued success in drug development strategies and services during the Outsourcing in Clinical Trials (OCT) West Coast conference, being held February 3-4 in Burlingame, California
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  • HHS Marks Goals for Alternative Payment Models

    Jan 26, 2015, 15:35 by Michael Croft
    Clinical Informatics News Brief | Secretary of Health and Human Services Sylvia Mathews Burwell today published a letter in the New England Journal of Medicine outlining near-term goals for influencing the direction of U.S. healthcare.
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  • PHT Expands Rater Training Program

    Jan 26, 2015, 10:00 by Michael Croft
    Clinical Informatics News Brief | PHT Corporation is expanding its rater training program that it first launched in November.
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  • Bill is Introduced to Provide Added Exclusivity for Fixed-Dose Drugs

    Jan 26, 2015, 00:00 by Michael Croft
    WSJ | A bill was introduced in Congress last week that is designed to alleviate frustration drug makers have felt over a recent FDA guidance concerning fixed-dose combination drugs.
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  • PHT Corporation Delivers Unique Rater Training Programs to Improve Instrument Reliability, Data Quality and Outcomes

    Jan 26, 2015, 00:00 by Michael Croft
    BOSTON, MA, UNITED STATES - Jan 26, 2015 - The pharmaceutical industry is further optimizing the collection of high quality electronic patient reported outcomes (ePROs) data for clinical research, with PHT CorporationRater Training programs
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  • KCR Launches Innovative CTMS Platform in Cooperation with Quadratek

    Jan 26, 2015, 00:00 by Michael Croft
    WARSAW, POLAND - Jan 26, 2015 - KCR, a Contract Research Organization (CRO) operating across 19 European countries and in the U.S., is developing an innovative clinical trial data platform based on the Clincase electronic data capture (EDC) and clinical data management (CDM) software delivered by Quadratek Data Service
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  • EMA Recommends Hundreds of Drugs to be Suspended Over ‘Flawed Studies’

    Jan 23, 2015, 00:00 by Michael Croft
    WSJ | European regulators recommend suspending the sale of hundreds of drugs that were authorized for use across the continent based on "flawed" clinical studies that were conducted by GVK Biosciences, a clinical research organization based in India.
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  • GenoSpace Welcomes Aspera's CEO to Board

    Jan 22, 2015, 12:00 by Michael Croft
    Clinical Informatics News | GenoSpace announced this morning that Michelle Munson, CEO of Aspera, an IBM Company, has joined its board as an independent director.
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  • Obama cybersecurity plug boosts profile of healthcare data security

    Jan 22, 2015, 00:00 by Michael Croft
    Modern Healthcare | Ten years ago, President George W. Bush briefly mentioned electronic health records in a State of the Union address and the federal government is now in the midst of a multibillion dollar effort to promote the technology. Can the same thing happen with cybersecurity?
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  • QIAGEN Gets European Approval for Lung Cancer Liquid Biopsy

    Jan 21, 2015, 15:00 by Michael Croft
    Clinical Informatics News | QIAGEN’s circulating tumor DNA companion diagnostic for lung cancer has been granted CE-IVD marking in 30 European countries, the company announced. The diagnostic is designed as a companion for Astra Zeneca’s IRESSA for non-small cell lung cancer patients.
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  • Mayo Clinic moves to Epic

    Jan 21, 2015, 00:00 by Michael Croft
    Healthcare IT News | In the latest example of a world-class health system yanking its established electronic health record in favor of a blue chip vendor, Mayo Clinic is migrating to Epic.
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  • Sharing Older Clinical Trial Data Should be Judicious

    Jan 21, 2015, 00:00 by Michael Croft
    WSJ | Ida Sim, a professor of medicine and at the University of California, San Francisco and a member of an Institute of Medicine committee, discusses a new IOM report on sharing clinical trial data.
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  • FDA Guidance on Regulating Wellness Apps

    Jan 20, 2015, 11:00 by Michael Croft
    MobiHealthNews | FDA has published a draft guidance to help wellness device and app makers more clearly understand which products are subject to FDA regulation and which are not.
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  • The Use of eSource Software in Phase I Clinical Trials

    Jan 20, 2015, 10:00 by Michael Croft
    Clinical Informatics News | Contributed Commentary | Clinical trial design has become more complex and the demands of the regulators ever more stringent, but clinical automation tools can make life easier on both counts. Clinical automation is a centralised software tool implemented within a clinical unit that supports volunteer recruitment, automates workflow through an electronic trial design schedule, drives operations at the clinical floor, and enables study data to be captured electronically (eSource), streamlining the clinical process. It also enables high quality data to be shared online, in real time, with the sponsor.
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