• Definiens Brings Big Data to the Tissue

    Feb 5, 2014, 10:05 by Michael Croft
    Clinical Informatics News | A partnership announced this week with Clarient Diagnostic Services, to provide a suite of breast cancer diagnostic tests, highlights how image analytic company Definiens is making "tissue phenomics" a partner to genomics in biomedical big data.
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  • BioOutsource To Open New Biosimilar Centre of Excellence in Glasgow as Global Demand Surges

    Feb 5, 2014, 00:00 by Michael Croft
    GLASGOW, UNITED KINGDOM - Feb 5, 2014 - BioOutsource Ltd. ("BioOutsource"), a global leader in biologics contract testing and biosimilar characterization for the biopharmaceutical industry, today announced the opening of a new Biosimilar Centre of Excellence in Glasgow
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  • HHS Revises Rules on Patient Access to Test Results

    Feb 4, 2014, 10:10 by Michael Croft
    Clinical Informatics News Brief | The U.S. Department of Health & Human Services announced yesterday that CLIA-certified labs will have new responsibilities to report test results directly to patients upon request.
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  • Apple and the FDA

    Feb 3, 2014, 10:10 by Michael Croft
    New York Times | High-level discussions between Apple executives and the FDA are fueling speculations that the IT titan may be hard at work on wearable health monitors.
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  • MiSeqDx Foreshadows Expanded Universe of Clinical Sequencing

    Feb 3, 2014, 08:30 by Michael Croft
    Clinical Informatics News | After last year's FDA approval of the first clinical next-generation sequencer, industry leader Illumina speaks to Clinical Informatics News about the company's plans to expand its diagnostic applications, and introduce a more powerful instrument to the clinic.
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  • At Last, a Draft Guidance on Social Media

    Jan 31, 2014, 10:00 by Michael Croft
    Clinical Informatics News | The long awaited draft guidance on social media, released by the Food and Drug Administration (FDA) on January 13, 2014, is in a 90-day comment period. The draft guidance spells out for the first time the agency’s thinking on when companies should make these submissions to FDA in this era of Facebook, Twitter, YouTube, and media blogs. 
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  • Johnson & Johnson Tries New Model for Data Transparency

    Jan 30, 2014, 12:35 by Michael Croft
    Xconomy | Johnson & Johnson today announced that an independent group at Yale will be empowered to review and grant scientific requests to see the full results of any clinical trial in the company's records.
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  • Adaptive Clinical Trial Designs Gradually Gaining Acceptance

    Jan 28, 2014, 10:00 by Michael Croft
    Clinical Informatics News | In an industry not known for change, more pharmaceutical companies are embracing adaptive clinical trial designs to boost success rates, decrease costs, and hasten timelines.  “This may be the Renaissance period for adaptive trial designs,” notes Kenneth Kaitin, PhD, Director of the Tufts Center for the Study of Drug Development.
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  • Miltenyi Biotec Receives FDA Approval for CliniMACS® CD34 Reagent System for Prevention of Graft-Versus-Host Disease in the Treatment of Acute Myeloid Leukemia

    Jan 24, 2014, 00:00 by Michael Croft
    BERGISCH GLADBACH, GERMANY - Jan 24, 2014 - Miltenyi Biotec announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic stem cell transplantation (SCT) from a matched related donor
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  • Novo Nordisk Chooses Social Media Recruitment Tool for Diabetes Studies

    Jan 23, 2014, 11:00 by Michael Croft
    Outsourcing Pharma | Novo Nordisk has chosen Trialbee to raise enrollment numbers in diabetes studies.
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  • The Evernote EMR

    Jan 23, 2014, 11:00 by Michael Croft
    Clinical Informatics News Brief | It seems the industry is still trying to strike the right balance in electronic health records: security, ease of use, connectivity are all a play. One man decided to build his own.
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  • Few Doctors Connect Patients to Clinical Trials

    Jan 22, 2014, 13:40 by Michael Croft
    PR Newswire | A survey by the Pancreatic Cancer Action Network shows that not only do few patients talk to their doctors about clinical trials after receiving a cancer diagnosis, but even fewer are connected to clinical trials after conventional treatments fail.
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  • Oregon's Public Health Plan - After the Medicaid Study

    Jan 22, 2014, 08:45 by Michael Croft
    Clinical Informatics News | The Oregon Medicaid Study's latest paper made headlines this month when it found a dramatic rise in emergency department visits among Medicaid enrollees. But in Oregon, a new model of public healthcare may be bending that trend back.
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  • Exco InTouch Successfully Completes HIPAA Security Audit

    Jan 20, 2014, 00:00 by Michael Croft
    NOTTINGHAM, UNITED KINGDOM - Jan 20, 2014 - Exco InTouch, the leading provider of patient engagement and data capture solutions for clinical research and healthcare providers, today announced that it has successfully undergone and completed an independent audit to assess compliance utilizing the National Institute of Standards and Technology (NIST) guidelines for Health Insurance Portability and Accountability Act (HIPAA) security
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  • CollabRx Links Breast Cancer App to Genomic Blood Test

    Jan 15, 2014, 12:00 by Michael Croft
    Clinical Informatics News | Patients of physicians who order the Cynvenio ClearID Breast Cancer genomic blood test will receive an annual subscription to a customized version of the CollabRx Therapy Finder app for breast cancer. 
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  • Can Clinical Trial Changes Increase Drug Approvals

    Jan 13, 2014, 08:05 by Michael Croft
    Clinical Informatics News | A Nature Biotechnology paper summarized the state of drug approvals from 2003 to 2012, and it’s not terribly encouraging. The answer, the authors suggest, might lie in trial design.
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  • Needs List for Clinical Decision Support

    Jan 9, 2014, 13:00 by Michael Croft
    InformationWeek | As Stage 2 Meaningful Use draws closer, some physicians are still struggling with Stage 1 regulations on Clinical Decision Support
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  • Potential Clinical Research Profits Elude Community Hospitals

    Jan 8, 2014, 14:00 by Michael Croft
    Clinical Informatics News | Clinical research trials are flourishing in community hospitals nationwide; however, many hospitals fail to generate a profit or develop a research infrastructure. Still others remain on the research sidelines, resulting in missed opportunities for enhanced revenue, community prestige, and retaining prominent physicians.
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  • New Look for Medical Data to Empower Patients

    Jan 8, 2014, 13:00 by Michael Croft
    TED Blog | Wired's former executive editor, Thomas Goetz, has launched a new company dedicated to reimagining health and drug data so that it can be better used by patients.
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  • Clinical Sequencing at the Molecular Medicine Tri-Conference

    Jan 2, 2014, 11:35 by Michael Croft
    Clinical Informatics News | 2014 will be the biggest year yet for the clinical use of genetic information. At the Molecular Medicine Tri-Conference in February, speakers from biotech industry and research will discuss the future of clinical sequencing, whether in cancer treatment, diagnostics, prenatal testing, or just general care.
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