• Operations commence at Wasdell Group’s EU headquarters

    Jul 19, 2019, 09:48 by Michael Croft
    - Jul 19, 2019 - The Wasdell Group (Wasdell), a leading outsourcing partner for the pharmaceutical industry, has today announced its new state-of-the-art facility in Dundalk, Ireland has received its Manufacturer’s / Importation Authorisation licence (MIA) from the Health Products Regulatory Authority (HPRA)
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  • Certara Expands its Drug Evidence & Access Capabilities Through the Addition of Compass Strategic Consulting’s Team

    Jul 18, 2019, 08:12 by Michael Croft
    PRINCETON, NJ - Jul 18, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that the entire staff from Compass Strategic Consulting (Compass) has joined Certara’s Evidence & Access group
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  • The Pistoia Alliance to Develop a Toolkit to Support Implementation of the FAIR Guiding Principles

    Jul 17, 2019, 06:45 by Michael Croft
    BOSTON, MA, UNITED STATES - Jul 17, 2019 - The Pistoia Alliance, a global non-profit that works to lower barriers to innovation in life sciences R&D, today announced the launch of its FAIR Implementation project, backed by pharmaceutical companies including Roche, Astra Zeneca, and Bayer
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  • Rho Announces New Resource for Behavioral and Social Science Researchers to Prepare Research Protocols

    Jul 16, 2019, 17:51 by Michael Croft
    DURHAM, NC - Jul 17, 2019 - Rho Announces New Resource for Behavioral and Social ScienceResearchers to Prepare Research ProtocolsCRO facilitated Trans-NIH committee to develop protocol template with NIDCR Research Triangle Park, NC - July 16, 2019 - Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, announced today that Rho's Principal Research Scientist and Program Lead Nancy Yovetich, PhD, and Project Manager Lisa Busko  participated in a trans-NIH + extramural committee to develop a standardized protocol template for behavioral and social science researchers
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  • Control Arm Supplementation: First Step Toward No-Placebo Trials

    Jul 16, 2019, 08:45 by Michael Croft

    Clinical Research News | Eliminating a study's control arm by substituting pre-existing real-world data (RWD) is an idea that has captured the imagination of industry sponsors looking to gain efficiencies and cost savings—and reduce participants' fears that they will be end up getting a placebo.

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  • The Human Microbiome Has Parallels With Forest Ecology

    Jul 15, 2019, 08:00 by Michael Croft

    Clinical Research News | The recently concluded Human Microbiome Project successfully captured host and microbial properties linked to disease in a trio of longitudinal studies. To microbiome researchers, comparing the human microbiome with forest ecology can be irresistible since it's a lot easier to see a tree than a bacterium.

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  • Speeding Drug Development For Kids With Cancer

    Jul 11, 2019, 13:20 by Michael Croft

    Clinical Research News | The current lag time between first-in-human and first-in-child clinical trials for kids with cancer is concerning to the early phase clinical trials program at the Dana-Farber/Boston Children's Cancer and Blood Disorders Center.

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  • PerkinElmer Launches CE-Marked Infectious Disease Immunoassays on EUROIMMUN Random Access Instrument

    Jul 10, 2019, 17:20 by Michael Croft
    WALTHAM, MA, UNITED STATES - Jul 10, 2019 - PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced the first two CE-marked chemiluminescence immunoassays (ChLIA) for the detection of anti-Borrelia (Lyme disease) and anti-EBV/EBNA (Epstein-Barr Virus) antibodies on its EUROIMMUN RA Analyzer 10 system
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  • Taking The Guesswork Out Of Trial Planning

    Jul 10, 2019, 10:10 by Michael Croft

    Clinical Research News | Companies like Oracle and Cytel are taking unique approaches to study start-up, hoping cross-vendor integration and workflow automation can simplify the global, complex clinical trial process.

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  • Atlantic Research Group Selects Greenphire to Improve the Patient Experience for its Rare Disease and Oncology Clinical Trials

    Jul 9, 2019, 13:52 by Michael Croft
    DEVON, PA, UNITED STATES - Jul 9, 2019 - Greenphire, the global leader in financial software for clinical trials, announced today that it has been selected by Atlantic Research Group (ARG), a rare and neurodegenerative disease, oncology and immunology-focused contract research organization (CRO) to implement its ClinCard and ConneX solutions to improve the clinical trial experience for sites and patients
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  • Under the spotlight: Amgen’s VP for the Center of Observational Research Will Discuss the Role of RWE in a Comprehensive Product Evidence Generation Plan

    Jul 9, 2019, 09:55 by Michael Croft
    BOSTON, MA, UNITED STATES - Jul 9, 2019 - Under the spotlight: Amgen's VP for the Center of Observational Research Will Discuss the Role of RWE in a Comprehensive Product Evidence Generation PlanAmidst a (r)evolution in pharmaceutical strategy, Real World Evidence is more than ever a key driver of growing innovation in product life cycle
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  • Certara Announces the Formation of a New Practice Area Focused on Global Health

    Jul 9, 2019, 09:43 by Michael Croft
    PRINCETON, NJ - Jul 9, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that it has formed a new practice area called Certara Global Health (CGH) to focus its technological expertise on helping to achieve equity in health for all people worldwide
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  • UnitedHealth Group Acquires PatientsLikeMe

    Jul 8, 2019, 15:30 by Michael Croft

    Clinical Research News Brief | UnitedHealth Group has acquired online patient community portal PatientsLikeMe as of June 19. As part of the acquisition, the startup will now become part of UnitedHealth Group’s research arm that focuses on healthcare improvements and innovation.

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  • Common Protocol Template Gaining Traction

    Jul 8, 2019, 11:40 by Michael Croft

    Clinical Research News | Growing numbers of study sponsors have been adopting the Common Protocol Template (CPT)—or at least its basic structure—since TransCelerate BioPharma released the first version in 2015.

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  • PHARMASEAL Launches Second Major Release of Engility CTMS

    Jul 8, 2019, 09:01 by Michael Croft
    NOTTINGHAM, UNITED KINGDOM - Jul 8, 2019 - PHARMASEAL, a new provider of clinical trial management and governance solutions to enter the market, announces a second major release of its Engility CTMS platform
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  • Solving Sponsors' Top 10 R&D Pain Points With Data Ingestion And Harmonization Platforms

    Jul 2, 2019, 08:45 by Michael Croft

    Clinical Research News Contributed Commentary | An overview of the top ten R&D pain points that state-of-the-art analytics solutions can solve for sponsors, both in the research and the development phases of a program's lifecycle, can provide an understanding of the benefits of AI-powered data ingestion and harmonization platforms.

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  • Aetion, Kit Check, Shimmer, And More: News From June 2019

    Jul 1, 2019, 08:00 by Michael Croft

    Clinical Research News | June was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Aetion, Kit Check, Shimmer, and more.

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  • Data-Driven Approaches Gaining Favor With Study Sponsors

    Jun 28, 2019, 07:55 by Michael Croft

    Clinical Research News | A succession of global clinical development executives and strategic planners at this year's SCOPE Summit spoke about the radical shift away from traditional feasibility questionnaires and opinions of people on the ground to select sites for trials.

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  • Right-Sizing Site Selection: Streamlining Feasibility

    Jun 27, 2019, 08:10 by Michael Croft

    Clinical Research News | A major step forward in making clinical trials less onerous to conduct has been recent sponsor focus on "reducing the amount of paperwork and bureaucracy" put on sites.

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  • Right-Sizing Site Selection: Tapping The Evidence

    Jun 26, 2019, 08:45 by Michael Croft

    Clinical Research News | Pfizer, Allergan, and Merck each take a decidedly different approach to selecting sites and investigators for clinical trials. But across the board, data plays a starring role.

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