• TrialAssure Creates Higher Education Discount Pricing Model For Clinical Trial Disclosure Reporting Software

    Jan 30, 2019, 14:05 by Michael Croft

    Clinical Research News Brief | TrialAssure announced a program called TrialAssure Academic Pricing (TAP) to assist universities globally through managing and disclosing all clinical trial results in a cost-efficient manner.

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  • TrialScope and Vivli Partner to Address Rapidly Growing Transparency Needs of Clinical Trial Sponsors and Researchers

    Jan 30, 2019, 13:09 by Michael Croft
    JERSEY CITY, NJ, UNITED STATES - Jan 29, 2019 -  TrialScope, the global leader in clinical trial transparency, compliance and patient engagement solutions, today announced a strategic partnership with Vivli, a nonprofit organization focused on sharing of clinical trial data through its innovative platform
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  • Align Clinical CRO, ZappRx, SAP, And More: News From January 2019

    Jan 30, 2019, 11:45 by Michael Croft

    Clinical Research News | January was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Align Clinical CRO, ZappRx, SAP, and more.

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  • WCG Acquires First Clinical Research, LLC

    Jan 30, 2019, 08:32 by Michael Croft
    PRINCETON, NJ - Jan 30, 2019 - The WIRB-Copernicus Group®’s (WCG™) Market Intelligence & Insights Division has acquired First Clinical Research LLC, organizer of the MAGI (Model Agreements & Guidelines International) Clinical Research Conference, which unifies the clinical research ecosystem by facilitating communication and the sharing of best practices among members
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  • Certara Launches Version 18 of its Physiologically-based Pharmacokinetic (PBPK) Simcyp Simulator

    Jan 29, 2019, 08:29 by Michael Croft
    PRINCETON, NJ - Jan 29, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced the launch of version 18 of its Simcyp® Population-based Simulator
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  • A Realist Looks At AI In Clinical Trials

    Jan 28, 2019, 12:50 by Michael Croft

    Clinical Research News | When assessing new technologies for clinical trials, one needs to be both visionary and skeptical. That seems to be even more true for AI technologies.

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  • FDA Announces New Guidances Focusing On Risk Evaluation And Mitigation Strategy

    Jan 24, 2019, 15:15 by Michael Croft

    Clinical Research News | The FDA's commissioner, Scott Gottlieb, released a statement today announcing the availability of two guidances that will help improve the agency’s ability to ensure that the risk mitigation programs put in place for certain drugs and biologics as a requirement of their approval are working.

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  • Aetna, Anthem, HCSC, PNC Bank, IBM To Establish Blockchain-Based Ecosystem For Healthcare Industry

    Jan 24, 2019, 12:00 by Michael Croft

    Clinical Research News Brief | Aetna, Anthem, Health Care Services Corporation (HCSC), PNC Bank, and IBM today announced a new collaboration to design and create a network using blockchain technology to improve transparency and interoperability in the healthcare industry.

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  • Modernizing Clinical Trials For Patients With Cancer

    Jan 24, 2019, 10:25 by Michael Croft

    JAMA Network | In this Viewpoint, directors at the National Cancer Institute (NCI) review reforms to the NCI clinical trials program, including use of historical controls and a push to reduce the financial pressures of clinical trials.

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  • Wasdell Group granted HPRA licence at new EU headquarters

    Jan 24, 2019, 07:12 by Michael Croft
    - Jan 24, 2019 - The Wasdell Group (Wasdell), a leading outsourcing partner for companies in the pharmaceutical and clinical trials industries, has been granted its Health Products Regulatory Authority (HPRA) licence for its new EU headquarters in Dundalk, Ireland
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  • Temperature-Stable Experimental Tuberculosis Vaccine Enters Clinical Testing

    Jan 23, 2019, 10:35 by Michael Croft

    National Institutes of Health (NIH) | Vaccinations have begun in a Phase 1 human clinical trial testing a freeze-dried, temperature-stable formulation of an experimental tuberculosis (TB) vaccine candidate.

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  • IDDI starts Collaborative Research on Ground-Breaking Statistical Method for individualization of Therapy

    Jan 23, 2019, 09:12 by Michael Croft
    , BELGIUM - Jan 23, 2019 - The treatment of patients in clinical practice relies on the results of randomized clinical trials. The statistical methods currently used to test the treatment effects in such trials take into account a single criterion called "primary endpoint"
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  • What Is Holding Back The Adoption Of eConsent?

    Jan 23, 2019, 08:20 by Michael Croft

    Clinical Research News | The eConsent field is challenging: on the one hand it represents a major improvement in the consenting process for clinical trial participants. On the other hand, it is fraught with regulatory uncertainties and industry ambiguity. Tearing apart this tangle will be necessary for eConsent to do what the technology is meant to do: inform trial participants and speed enrollment.

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  • Niche Biometric CRO launches dedicated pharmacovigilance business

    Jan 23, 2019, 04:10 by Michael Croft
    LONDON, UNITED KINGDOM - Jan 15, 2019 - LONDON (UK) - Quanticate, a leading global data-focused clinical research organisation (CRO) has launched QVigilance to provide dedicated pharmacovigilance (PV) and risk management services
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  • ERT Achieves Milestone in Contributing to its Communities

    Jan 22, 2019, 11:10 by Michael Croft
    PHILADELPHIA, PA, UNITED STATES - Jan 22, 2019 - ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced it reached a new charitable contribution milestone in 2018
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  • PHARMASEAL Launches Engility CTMS, an Innovative Clinical Trial Management Platform for Unified Governance

    Jan 22, 2019, 09:37 by Michael Croft
    NOTTINGHAM, UK - Jan 22, 2019 - PHARMASEAL, a new provider of clinical trial management and governance solutions to enter the market, has launched EngilityÔ CTMS, the first product to be released from its Engility B2B platform
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  • 3 Blockchain Apps Up For Adoption In 2019

    Jan 22, 2019, 08:00 by Michael Croft

    Clinical Research News | A trio of blockchain-enabled applications that debuted at the recent Distributed: Health conference in Nashville, Tennessee, could start giving patients more control over their personal health data as early as next year.

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  • Clinical Research News: New Title, Broader Focus

    Jan 21, 2019, 14:15 by Michael Croft

    Clinical Research News | For more than 15 years, the team behind Clinical Informatics News has been covering technology and trends in the clinical research space. Now, we are announcing a new name and brand to better reflect that broad and passionate scope: Clinical Research News.

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  • FDA Exploring New Approach To Software Oversight

    Jan 18, 2019, 11:35 by Michael Croft

    Clinical Informatics News | A trio of new FDA documents released January 7 suggests the agency is trying to create a new oversight paradigm for Software as a Medical Device (SaMD) that is better aligned to the realities of software development without updating existing regulations or issuing new ones.

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  • Another Tool In The Toolbox: AI’s Application In Clinical Trials

    Jan 17, 2019, 09:45 by Michael Croft

    Clinical Informatics News | The promise of AI’s impact on clinical trials has many experts both bewildered and skeptical. A panel at the AI World Conference & Expo looked past the hype and discussed practical application.

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