• The Confidential Reasons Drugs Are Rejected by the FDA

    Jun 15, 2015, 11:05 by Michael Croft
    Clinical Informatics News | The FDA has published a study to assess whether its reasons for rejecting drugs and medical devices — currently kept confidential unless the sponsors of trials choose to release them — are effectively reaching the public, concluding that there are stark discrepancies between what the FDA tells companies about their products and what those companies report in public.
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  • Paragon Solutions Life Sciences R&D Practice Appoints Leader for Regulatory Domain

    Jun 15, 2015, 00:00 by Michael Croft
    CRANFORD, NJ, UNITED STATES - Jun 15, 2015 - Paragon Solutions, an advisory consulting and systems integration firm, announces regulatory affairs and operations expert Brooke Casselberry will lead its Life Sciences R&D Regulatory Domain
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  • Comprehend Systems Launches Quality Solution to Help Clinical Operations Leaders Deliver Quality Results, Faster

    Jun 15, 2015, 00:00 by Michael Croft
    WASHINGTON, DC - Jun 15, 2015 - Today Comprehend Systems, Inc., the leader in clinical software solutions, announced the launch of Continuous Quality for ClinOps, a solution that enables clinical operations (ClinOps) to deliver high quality clinical trial submissions at a new speed
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  • MasterScope® 2 Successfully Deployed in Respiratory Clinical Trials

    Jun 15, 2015, 00:00 by Michael Croft
    PHILADELPHIA, PA, UNITED STATES - Jun 15, 2015 - ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions,today announced that MasterScope® 2, its comprehensive diagnostic platform for spirometry, electrocardiogram (ECG) and home monitoring, has been successfully implemented in multiple clinical trials from leading pharmaceutical companies
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  • Foundation Medicine Connects Mutations, Treatment Plans for Personalized Care

    Jun 12, 2015, 09:00 by Michael Croft
    Clinical Informatics News | Foundation Medicine has launched PatientMatch, a tool to connect doctors who are treating patients with similar rare genetic mutations. At Sarah Cannon Research Institute, physicians are finding it useful for connecting patients to the right drug trials as well.
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  • Stanford Pharmacovigilance Program Suggests New Drug Risks

    Jun 11, 2015, 11:35 by Michael Croft
    Washington Post | A project by scientists at Stanford University to monitor a large set of electronic health records has uncovered a probable link between extended use of proton pump inhibitors, including Nexium and Prilosec, and an increased risk of heart attack.
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  • ERT Announces Availability of Site Selection Analytics for Insights Cloud™

    Jun 11, 2015, 00:00 by Michael Croft
    PHILADELPHIA, PA, UNITED STATES - Jun 11, 2015 - ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, today announced the addition of Site Selection Analytics within the ERT Insights Cloud
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  • Pharmaceutical Development Executive Jeffrey Kasher, Ph.D., Joins DrugDev as Chairman of Advisory Board

    Jun 11, 2015, 00:00 by Michael Croft
    KING OF PRUSSIA, PA, UNITED STATES - Jun 11, 2015 - DrugDev continues to attract pharmaceutical industry visionaries to join its mission of developing innovative clinical technology solutions to help sponsors, CROs and sites do more trials together
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  • ERT Showcases Scientific and Technological Expertise in Advancing Clinical Trial Technologies at DIA 51st Annual Meeting

    Jun 9, 2015, 00:00 by Michael Croft
    PHILADELPHIA, UNITED STATES - Jun 9, 2015 - ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions will embody the theme “Develop, Innovate, Advance” at the 51st Drug Information Association (DIA) Annual Meeting in Washington, DC, June 14-18, 2015
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  • ERT Integrates Remote Biosensor Patch with Electronic Clinical Outcome Assessment System

    Jun 9, 2015, 00:00 by Michael Croft
    PHILADELPHIA, UNITED STATES - Jun 9, 2015 - ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, today announced the integration of an innovative wearable biosensor which captures and wirelessly transmits real-time, continuous, clinical-grade biometric measurements into the ERT electronic Clinical Outcome Assessment (eCOA) system
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  • Rho Chairman and Co-Founder Ronald W. Helms Inducted as a Fellow Of the Society for Clinical Trials

    Jun 5, 2015, 00:00 by Michael Croft
    CHAPEL HILL, NC - Jun 5, 2015 - For Immediate Release Rho Chairman and Co-Founder Ronald W. Helms Inducted as a FellowOf the Society for Clinical Trials Chapel Hill, NC  ̶  June 4, 2015  ̶  Rho, a contract research organization (CRO) focused on bringing new products to market through a full range of product development services, recently announced that its Chairman and Co-founder Ronald W
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  • ERT Announces Availability of Wireless ECG /eCOA Tablet Integration(2)

    Jun 4, 2015, 00:00 by Michael Croft
    PHILADELPHIA - Jun 4, 2015 - ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, today announced the availability of a new solution to wirelessly integrate ECG data collection with an electronic Clinical Outcome Assessments (eCOA) tablet - reducing site burden while improving data quality in clinical research
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  • ERT Announces Availability of Wireless ECG /eCOA Tablet Integration

    Jun 4, 2015, 00:00 by Michael Croft
    PHILADELPHIA - Jun 4, 2015 - ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, today announced the availability of a new solution to wirelessly integrate ECG data collection with an electronic Clinical Outcome Assessments (eCOA) tablet - reducing site burden while improving data quality in clinical research
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  • Certara Endows Lectureship in Precision Dosing at The University of Manchester, England

    Jun 3, 2015, 00:00 by Michael Croft
    PRINCETON, NJ - Jun 3, 2015 - Certara®, the global biosimulation technology-enabled drug development consultancy, today announced that it is endowing a new three-year, full-time position – the Certara Lecturer in Precision Dosing – at the Manchester Pharmacy School, The University of Manchester, England
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  • Definiens Releases Biomarker Datafication Services for Oncology Clinical Development

    Jun 2, 2015, 00:00 by Michael Croft
    MUNICH, GERMANY - Jun 2, 2015 - Definiens, the global leader in image analysis for digital pathology and diagnostics, today announced a new suite of Biomarker Datafication Services for oncology clinical development programs
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  • May Clinical News and Product Briefs

    Jun 1, 2015, 12:25 by Michael Croft
    Clinical Informatics News | Clinical news and product briefs from around the industry, including a HIPAA-compliant email system from Virtru and a study of crowdfunding in rare hereditary disease initiatives.
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  • Amplifying the Patient Voice

    May 29, 2015, 07:40 by Michael Croft
    Clinical Informatics News | PatientsLikeMe has built the data structure of its social network on the “patient voice,” the language patients use to describe their own symptoms and experience. That has opened up new discoveries about chronic disease, but translating this patient vocabulary into formal clinical taxonomies is a challenge for the whole industry.
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  • Cenduit Reaches New Milestone of More Than 400 Employees

    May 29, 2015, 00:00 by Michael Croft
    RESEARCH TRIANGLE PARK, NC, UNITED STATES - May 29, 2015 - Cenduit, a joint venture between Quintiles and Thermo Fisher Scientific, today announced it has achieved a new milestone of more than 400 employees
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  • Eric Topol's Predictions for Medicine's Next 20 Years

    May 28, 2015, 00:00 by Michael Croft
    Medscape | As Medscape marks its 20th year in online medical publishing, Editor-in-Chief Eric Topol makes his predictions for the next 20 years in medicine.
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  • Rho Named a Best CRO with Life Sciences Award from the Triangle Business Journal

    May 28, 2015, 00:00 by Michael Croft
    CHAPEL HILL, NC - May 28, 2015 - Rho Named a Best CRO with Life Sciences Award
    from the Triangle Business Journal
     Chapel Hill, NC  ̶  May 27, 2015  ̶  Rho, a contract research organization (CRO) focused on bringing new products to market through a full range of product development services, recently announced that the company was recognized as one of the Best CROs by the Triangle Business Journal, a multimedia source for local business news, research and events in the Raleigh, Durham, Chapel Hill region of North Carolina, where Rho is headquartered
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