• Uber Launches Uber Health, Looks To Improve Patient Experience In Clinical Research

    Apr 11, 2018, 08:20 by Michael Croft

    Clinical Informatics News | Uber is looking to expand their outreach to the clinical research community with the launch of Uber Health, a new dashboard the company hopes will remove transportation as a barrier to proper care.

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  • We Need To Get Studies Organized Before FSFV

    Apr 10, 2018, 08:15 by Michael Croft

    Clinical Informatics News | It’s is about time we get everything in place for first-subject-first-visit (FSFV) before we start scheduling visits and seeing subjects.

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  • Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback?

    Apr 6, 2018, 12:19 by Michael Croft
    Kaiser Health News |  "Pre$cription for Power," a database to expose Big Pharma's ties to patient groups, has recently been launched by KHN.
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  • First Annual Model-informed Drug Development Gran Prix Deemed a Success

    Apr 5, 2018, 14:15 by Michael Croft
    PRINCETON, NJ - Apr 5, 2018 - Certara®, the global leader in model-informed drug development and regulatory science, and faculty at the UNC Eshelman School of Pharmacy today announced the winners of the first Model-informed Drug Development (MIDD) Gran Prix
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  • Evidentiary Equilibrium: Difficult To Attain But Not Impossible In Real-World Research

    Apr 4, 2018, 08:20 by Michael Croft

    Clinical Informatics News Contributed Commentary | Drug manufacturers plan Phase II-III research with utmost care, but all too often regard Real World Evidence (RWE) generation in Phase IV as a check-box activity. Not surprisingly, this approach is rarely successful.

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  • Platypus: Deep Data Dives For Clinical Data Reviewer

    Apr 3, 2018, 08:43 by Michael Croft
    Bio-IT World |  If you are creating a tool designed to give a sixth sense, of course you name it after a semiaquatic, egg-laying mammal endemic to eastern Australia. Not unlike the animal, Takeda's Platypus is made up of various parts, specifically designed to meet the medical reviewer's needs.
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  • The Government Wants To Free Health Data. Will That Unleash Innovation?

    Mar 29, 2018, 09:41 by Michael Croft
    STAT |  The Centers for Medicare and Medicaid Services wants to put patients in charge of their information - and it wants to do so explicitly to help app and device makers gain access to high-quality data.
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  • goBalto, Medial EarlySign, Veeva Systems, And More: News From March 2018

    Mar 28, 2018, 07:45 by Michael Croft

    Clinical Informatics News | March was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from goBalto, Medial EarlySign, Veeva Systems, and more.

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  • BioIVT Acquires Ascendance Biotechnology, Expanding its Drug Safety Testing and Toxicology Portfolios

    Mar 27, 2018, 11:01 by Michael Croft
    PRINCETON, NJ - Mar 27, 2018 - BioIVT, a leading provider of biospecimens and related services, today announced that it has acquired Ascendance Biotechnology, Inc
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  • WCG (WIRB-Copernicus Group) Clinical Services Division Acquires ACI Clinical

    Mar 27, 2018, 08:58 by Michael Croft
    PRINCETON, NJ - Mar 27, 2018 - WCG™ (WIRB-Copernicus Group®) Clinical Services Division, the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, today announced its acquisition of ACI Clinical, the top provider of Endpoint Adjudication and Data Monitoring Safety Committees
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  • Sequencing Patients' Genomes Might Not Break The Health Care Bank

    Mar 22, 2018, 11:48 by Michael Croft
    STAT |  The first rigorous study of its kind finds that sequencing people's genomes might not lead to extensive and expensive follow-up care, researchers reported.
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  • ERT Launches Phase I Site Certification Program to Improve Efficiencies in Clinical Development

    Mar 22, 2018, 10:45 by Michael Croft
    PITTSBURGH, PA, UNITED STATES - Mar 22, 2018 - ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced it has launched a certification program for Phase I investigative sites conducting cardiac safety studies
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  • Bio-Optronics and Synexus Align to Further Optimize Global Research Operations

    Mar 22, 2018, 10:19 by Michael Croft
    ROCHESTER, NY, UNITED STATES - Mar 22, 2018 - Bio-Optronics, the creator of the market-leading Clinical Conductor Clinical Trial Management System (CTMS) announces a new partnership with Synexus, the world’s largest site network organization
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  • Rho Announces New Director of Quality Assurance and VP of Clinical Operations

    Mar 20, 2018, 09:23 by Michael Croft
    CHAPEL HILL, NC, UNITED STATES - Mar 20, 2018 - Rho, a contract research organization (CRO) focused on bringing new products to market through a full range of product development services, today announced that Lysa Triantafillou and Matt Healy have joined its team as director of quality assurance and vice president, clinical operations, respectively, at its headquarters in Chapel Hill, North Carolina
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  • SCOPE 2018: What Was Seen, What Was Heard

    Mar 20, 2018, 08:20 by Michael Croft

    Clinical Informatics News | Several weeks out from the event, we’ve provided a summary of the latest to come from the 2018 Summit for Clinical Ops Professionals.

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  • FDA Releases First Clinical Study Report For Approved Janssen Drug

    Mar 19, 2018, 15:10 by Michael Croft
    Clinical Informatics News  Today FDA posted the first Clinical Study Report (CSR) as part of its Clinical Data Summary Pilot, an effort to increase drug approval transparency announced by FDA Commissioner Scott Gottlieb in January. The first CSR comes from Janssen Biotech for the approval of Erleada (apalutamide), the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer, as well the first to use the clinical trial result, or endpoint, of metastasis-free survival.
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  • The Pistoia Alliance Calls for Greater Life Sciences Collaboration to Build the ‘Lab of the Future’

    Mar 19, 2018, 07:17 by Michael Croft
    LONDON - Mar 19, 2018 - The Pistoia Alliance, a global, not for profit alliance that works to lower barriers to innovation in life sciences R&D, is calling upon the industry to support the ‘Lab of the Future’ (LoTF) through greater collaboration
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  • Survey Says: Patients Willing, Investigators Warning Of Mobile Trial Opportunities And Challenges

    Mar 15, 2018, 10:50 by Michael Croft

    Clinical Informatics News | The Clinical Trials Transformation Initiative (CTTI) conducted a survey of potential research participants as part of its Mobile Clinical Trials program. The results are in. Trial participants are enthusiastic about mobile trials, and challenges for sites and investigators are being better defined and addressed.

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  • KCR’s #HBEN project won the iF DESIGN AWARD 2018!

    Mar 15, 2018, 09:19 by Michael Croft
    BERLIN, GERMANY - Mar 15, 2018 - KCR’s patient-centric project #HumanBehindEveryNumber (#HBEN) won the iF DESIGN AWARD 2018. The project was recognized in the category of “Professional Concept – Health
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  • Certara Launches Industry-First Quantitative Systems Pharmacology (QSP) Consortium on Immuno-oncology with Leading Pharma Company Members

    Mar 13, 2018, 10:08 by Michael Croft
    PRINCETON, NJ - Mar 13, 2018 - Certara®, the global leader in model-informed drug development and regulatory science, today announced the launch of its Quantitative Systems Pharmacology (QSP) Immuno-oncology Simulator Consortium
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