• Big Pharma Creates One-Stop Shop for Investigator Sites

    May 18, 2016, 05:35 by Michael Croft
    Clinical Informatics News | TransCelerate BioPharma’s Shared Investigator Platform (SIP) Initiative—launched in January—has its sights set on changing the relationship between sites and pharmaceutical companies working on clinical trials. “It is absolutely the first of its kind,” said Jackie Kent, TransCelerate’s SIP Initiative leader.
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  • ERT Integrates Circassia’s FeNO Device to Assess Patient Airway Inflammation

    May 17, 2016, 15:38 by Michael Croft
    PHILADELPHIA, PA, UNITED STATES - May 17, 2016 - ERT, a leading provider of high-quality patient data collection solutions for use in clinical drug development, today announced it has successfully integrated the market-leading Fractional exhaled Nitric Oxide (FeNO) measurement device by Aerocrine—a Circassia subsidiary— into ERT’s diagnostic platform for spirometry, ECG and home monitoring for centralized clinical trials
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  • FDA Releases Draft Guidance on EHR Use in Clinical Trials

    May 17, 2016, 06:40 by Michael Croft

    Clinical Informatics News | The US Food and Drug Administration yesterday released a 12-page draft guidance on the “Use of Electronic Health Record Data in Clinical Investigations.” The draft guidance is intended to modernize and streamline clinical investigations, the Agency stated, promoting the use of electronic health records in clinical investigations.

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  • Technology Can’t Solve Slavitt’s “Data Paradox”

    May 16, 2016, 21:56 by Michael Croft
    The Health Care Blog |  Andy Slavitt began his statement at the Datapalooza conference with encouraging words for those of us who believe that the measurement craze has been a disaster and that MACRA will make it worse. But the rest of Slavitt's statement reveals he has no idea how to solve the "data paradox."
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  • Preclarus Enables Faster Insights to Improve Clinical Trial Efficiency and Quality

    May 13, 2016, 10:10 by Michael Croft
    Clinical Informatics News | Best Practices Finalists | To manage large amounts of data stored in different systems, PPD created Preclarus: dashboards that offer real-time, interactive visualizations and analytics that let users drill down into data for detailed information.
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  • Datapalooza MACRA EHR Reform and Working with Doctors – Not Against Them

    May 12, 2016, 12:02 by Michael Croft
    The Health Care Blog |  Healthcare technology supports us in getting coverage, but it's failing us in the care experience.
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  • Dr. Adam Darwich is Appointed Certara Lecturer in Precision Dosing at The University of Manchester, England

    May 12, 2016, 09:10 by Michael Croft
    PRINCETON, NJ - May 12, 2016 - Certara®, the global biosimulation technology-enabled drug development company, today announced that Adam Darwich, PhD, has been appointed Certara Lecturer in Precision Dosing at the Manchester Pharmacy School at The University of Manchester in England
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  • PerkinElmer Sells LIMS Product to New LIMS Company

    May 11, 2016, 14:30 by Michael Croft
    Clinical Informatics News Brief | PerkinElmer Health Sciences has sold its LABWORKS LIMS product line to Labworks, LLC, a new company comprising many previous PerkinElmer/LABWORKS employees. The LABWORKS LIMS product line has a 25-year history of LIMS excellence and a 300+ customer base. No financial details were released.
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  • STAT-Harvard poll Public wary of faster FDA approvals of drugs

    May 11, 2016, 10:09 by Michael Croft
    STAT |  A majority of Americans opposes regulatory changes to speed up the approval of new drugs and medical devices, a new STAT-Harvard poll finds.
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  • The pressure to publish pushes down quality

    May 11, 2016, 10:09 by Michael Croft
    Nature News & Comment |  Scientists must publish less, says Daniel Sarewitz, or good research will be swamped by the ever-increasing volume of poor work.
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  • Clintrax Global Named as Finalist for Triangle Business Journal’s 2016 Life Sciences Awards

    May 11, 2016, 09:50 by Michael Croft
    PRINCETON, NJ - May 11, 2016 - WIRB-Copernicus Group® (WCG™), one of the world's leading providers of solutions that measurably improve the quality and efficiency of clinical research, today announced that its Clintrax Global company has been named a finalist for the Triangle Business Journal’s (TBJ’s) 2016 Life Sciences Awards
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  • Definiens’ Symposium Finds Tissue Context of Tumor is Key to Cancer Immunotherapy Success

    May 10, 2016, 15:28 by Michael Croft
    MUNICH, GERMANY - May 10, 2016 - Definiens, the pioneer in Tissue Phenomics® solutions for diagnostics development, has announced findings from the International Symposium, a sold-out gathering of international researchers and clinicians on April 27-28 in Boston, Massachusetts to discuss advancements in oncology and the application of Tissue Phenomics
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  • Defining & Building Protocol Competitiveness

    May 10, 2016, 04:50 by Michael Croft

    Clinical Informatics News | Everybody is fighting for the same patient pool. To develop an advantage, AstraZeneca and Anolinx are collaborating on a competitive strategy by creating a trial design library, pseudo populations, increasing clinical efficiency, and generating a new clinical buzz word with an old idea.

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  • Best Practices: Risk Based Monitoring For A Small Staff

    May 6, 2016, 10:45 by Michael Croft
    Clinical Informatics News | Best Practices Finalists | When PaxVax, a small vaccine biotech, wanted to run a Phase IV trial with only its existing staff, it turned to MANA Consulting to build a workflow for risk-based monitoring that would fit within its existing budget.
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  • PharmaSeek Partners with PRCCI to Enhance Clinical Research in Puerto Rico

    May 4, 2016, 11:29 by Michael Croft
    MIDDLETON, WI, UNITED STATES - May 4, 2016 - PharmaSeek LLC, an Investigative Site Network (ISN), is expanding the reach of its network by partnering with the Puerto Rico Consortium for Clinical Investigation (PRCCI)
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  • Envera Health raises $14M for patient engagement platform

    May 4, 2016, 10:22 by Michael Croft
    MobiHealthNews |  Richmond, Virginia-based patient engagement company Envera Health has raised $14 million in a round led by Harbert Venture Partners and Noro-Moseley Partners with participation from New Richmond Ventures.
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  • IMS Health, Quintiles Announce Merger

    May 3, 2016, 13:45 by Michael Croft
    Clinical Informatics News Brief | IMS Health Holdings, Inc. and Quintiles Transnational Holdings Inc. announced today that their respective boards of directors approved a definitive merger agreement, in which the companies will be combined in an all-stock merger of equals transaction. The merged company will be named Quintiles IMS Holdings, Inc.
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  • Personalized Trials: Finding the Right Trial for the Patient

    May 3, 2016, 08:10 by Michael Croft
    Clinical Informatics News | A team of bioinformaticians at Cincinnati Children’s Hospital has applied machine learning to predict which patients will participate in clinical trials. When physicians approached patients, 60% of them agreed to participate in trials. Using an algorithm to predict trial interest, the researchers pushed the acceptance rates to 72%.
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  • FDA Slowly Chips Away at ANDA Backlog

    May 2, 2016, 12:41 by Michael Croft
    RAPS |  The number of abbreviated new drug applications (ANDAs) pending review is declining according to the latest numbers from FDA. Instead, FDA is waiting to hear industry responses.
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  • CBER Unveils New Electronic Reporting System for Vaccine Adverse Events

    Apr 28, 2016, 12:57 by Michael Croft
    RAPS |  FDA's Center for Biologics Evaluation and Research has released an electronic submission system for companies to submit adverse events linked to vaccines.
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