• 21st Century Cures Act Would Have Let Failed Alzheimer's Drugs Slip Through

    Nov 24, 2015, 12:13 by Michael Croft
    FierceBiotech |  The National Center for Health Research warns that the 21st Century Cures Act, now under consideration by Congress, would open substantial loopholes for ineffective drugs - reflecting on how three failed Alzheimer's drugs would have fared if the act had been in effect.
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  • The Importance of an eCOA Device Supply Strategy in Global Clinical Trials

    Nov 23, 2015, 11:55 by Michael Croft

    Clinical Informatics News | Contributed Commentary | Over the past decade, electronic Clinical Outcome Assessment (eCOA) has become increasingly popular in global clinical trials thanks to the technology’s ability to provide more complete data collection, boost compliance, and manage patients in real-time. Despite its proven record in supporting clinical trials of all sizes and complexities, many sponsors and CROs still have reservations about implementing eCOA. 

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  • Optimizing the Pipeline: Making Genomics In the Clinic a Reality

    Nov 20, 2015, 12:00 by Michael Croft

    Clinical Informatics News | Today HudsonAlpha held the grand opening for the Smith Family Clinic for Genomic Medicine, a collaboration between the HudsonAlpha Institute, the University of Alabama at Birmingham; and Children's of Alabama, a pediatric medical center.

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  • CLARITY Challenge Results Show Disparity in Reporting

    Nov 18, 2015, 12:10 by Michael Croft
    Clinical Informatics News | Results are in for the CLARITY Undiagnosed challenge, a crowdsourced competition sponsored by the Manton Center for Orphan Disease Research at Boston Children's and the Department of Biomedical Informatics (DBMI) at Harvard Medical School.
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  • Speeding Study Startup Through Better Collaboration and Data Flow

    Nov 16, 2015, 10:55 by Michael Croft
    Clinical Informatics News Contributed Commentary | A critical question facing many sponsors and contract research organizations is whether another system to support study startup is really needed. It’s a fair question in the clinical world where the urgent need for better execution of clinical trials has led to a proliferation of technologies, namely the clinical trial management system; the electronic trial master file; electronic data capture; and others. Each of these solutions focuses on specific pieces of the clinical trial continuum, yet, they overlook aspects unique to SSU, a complex process that continues to stumble and stall clinical trial timelines.
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  • Clinical Decision Alerts Poorly Tailored to Purpose in Opioid Prescriptions

    Nov 13, 2015, 11:15 by Michael Croft
    EHR Intelligence | A study in Annals of Emergency Medicine has shown that clinical decision alerts designed to prevent adverse events from opioids have extremely low specificity, presenting doctors with over 120 unnecessary alerts for every one adverse event prevented.
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  • Drug makers kept many clinical trial results a secret study

    Nov 12, 2015, 14:58 by Michael Croft
    Pharmalot |  In a study of 318 clinical trials, 35% of results were not disclosed. Glaxo, J&J, and Pfizer were the most transparent pharma companies, releasing all of the trial data for drugs approved in 2012. Gilead Sciences and Sanofi disclosed the least trials.
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  • Galen Healthcare Solutions Names Steve Brewer CEO

    Nov 12, 2015, 11:56 by Michael Croft
    CHICAGO, IL, UNITED STATES - Nov 12, 2015 -  Galen Healthcare Solutions Named to Modern Healthcare  List of"Top Places to Work" for 3rd Consecutive Year Announces Steve Brewer as New CEO Galen Healthcare Solutions, a services and solutions company focusing on healthcare information technology, today announced that Steve Brewer has been named Chief Executive Officer
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  • Diagnostic Errors Test the Promise and Limitations of HIT

    Nov 12, 2015, 09:40 by Michael Croft
    Diagnostics World | Following a recent report from the Institute of Medicine that concludes most Americans will receive at least one misdiagnosis in their lifetimes, Drs. Hardeep Singh and Mark Graber have published recommendations in the New England Journal of Medicine for reforms, both technological and cultural, to address the issue of diagnostic error.
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  • WIRB-Copernicus Group Launches Nonprofit WCG Foundation to Improve Global Clinical Research

    Nov 12, 2015, 09:28 by Michael Croft
    PRINCETON, NJ - Nov 12, 2015 - WIRB-Copernicus Group® (WCG™), the world’s largest provider of regulatory and ethical review services and software to support clinical research, today announced the launch of WCG Foundation
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  • EMC hospital to pay $90000 over stolen laptop with medical data

    Nov 9, 2015, 14:35 by Michael Croft
    Computerworld |  Medical data security gets expensive. EMC and Hartford Hospital have agreed to pay $90,000 to Connecticut for the loss in 2012 of an unencrypted laptop containing patient information of 8,883 residents of the state, according to the state's attorney general.
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  • Seven Major Cancer Centers to Pool Genetic and Health Data

    Nov 9, 2015, 11:49 by Michael Croft
    Xconomy |  A consortium of cancer centers, aided by Sage Bionetworks, is hoping that sharing health records and genetic testing results will demonstrate a clinical benefit to exploratory sequencing in cancer cases.
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  • Platform Integration Can Boost Pharmacovigilance

    Nov 9, 2015, 11:00 by Michael Croft
    Clinical Informatics News | Contributed Commentary There’s been a lot of talk within the industry about how integrating electronic data capture (EDC) platforms used within the clinical research industry with platforms used to create, manage and store electronic health records (EHR) could benefit physicians, healthcare institutions and pharmaceutical companies. But there is an additional benefit that directly impacts improvements in patient safety that has been less noticed: how EDC/EHR integration can actually make existing drugs, therapeutics and medical devices safer for patients.
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  • University of Chicago Graham School Launches Master of Science Degree in Biomedical Informatics

    Nov 5, 2015, 12:04 by Michael Croft
    CHICAGO, IL, UNITED STATES - Nov 5, 2015 - Biomedical informatics, one of the world’s fastest-growing interdisciplinary fields, is the latest graduate degree program offered by the University of Chicago Graham School of Continuing Liberal and Professional Studies
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  • Bluebird Gene Therapy Trial Shows Promising but Nuanced Results

    Nov 5, 2015, 09:25 by Michael Croft
    TheStreet |  Bluebird Bio has released new interim results from its clinical trial of LentiGlobin gene therapy for beta-thalassemia and sickle cell disease, showing that it can wean patients off blood transfusions but that results are unexpectedly dependent on recipients' exact genotypes.
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  • ERT Achieves Record Third Quarter Results & Recognizes 40% Growth

    Nov 5, 2015, 08:28 by Michael Croft
    PHILADELPHIA, PA, UNITED STATES - Nov 5, 2015 - ERT, the leading cloud platform solutions provider delivering clinical and scientific innovation through its patient-centric data collection and intelligence solutions, today announced record bookings results throughout third quarter, 2015
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  • Fixing The Healthcare Dichotomy

    Nov 4, 2015, 11:35 by Michael Croft
    TechCrunch |  Private industry and government alike are increasingly banking on APIs to resolve communication problems between electronic health records and other data silos in healthcare.
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  • Best Practices Call for Entries Open

    Nov 4, 2015, 09:40 by Michael Croft
    Clinical Informatics News | The third annual Clinical Informatics News Best Practices program is open for entries. The 2016 winners will be announced in February in Miami at the Summit for Clinical Ops Executives.
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  • Canbex Therapeutics Announces Start of Phase II Trial of VSN16R for Spasticity

    Nov 2, 2015, 07:10 by Michael Croft
    LONDON, UNITED KINGDOM - Nov 2, 2015 - Canbex Therapeutics Ltd today announced that its novel orally active medication for the treatment of spasticity, VSN16R, has entered a Phase II trial in patients with spasticity caused by multiple sclerosis
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  • FDA Equips its Pharmacometrics Teams with Certara’s Phoenix Software

    Nov 2, 2015, 03:51 by Michael Croft
    PRINCETON, NJ - Nov 2, 2015 - Certara®, the global biosimulation technology-enabled drug development company, today announced that the United States Food and Drug Administration (FDA) has outfitted its pharmacometrics teams with Certara’s Phoenix® software
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