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PHT: Nonstop Innovation

PHT: Nonstop Innovation

Influencing Clinical Research, Industry and Regulators

PHT – Where “What Comes Next” Happens Every Day

The passion for changing clinical research through patient-driven information is threaded throughout PHT culture and industry influence.

PHT has helped transform the clinical trial industry from relying on paper source documents to embracing electronic source (eSource) data and improving the quality and throughput of clinical research.

PHT is a founding member of CDSIC and the ePRO Consortium and has consulted with regulators around the globe on the benefits eSource and eCOA systems provide to the researchers, regulators and the public.

  • PHT Innovations for eCOA

  • Innovation and Leadership: Patents

    • Time travel patent for clinical investigation data logging with contextual time shifting.
    • Data processing patent which ensures that all transmitted data are secure and stored in at least three places at all times.
    • Health monitoring system patent which tracks patient health.
    • Programming device memory patent to facilitate program management, and to speed up compilation.
    • Health monitoring system patent including an ingestible capsule containing medication.
    • Health tracking system which compiles a chronological patient health history.

  • PHT Regulatory Contributions

    • Co-presented at FDA on eSource and Part 11
    • Contributed to CSUCT, CSUICI, EMA Reflection Document on eSource, PRO Guidance, draft eSource Guidance, MDDS.
    • Trained FDA, PMDA (Japan), BfArM (Germany) on eSource Archives.

  • PHT eClinical Contributions

  • PHT PRO Development Contributions

    • ePRO Consortium Founding members
    • ISPOR Task Force member
    • National Cancer Institute Clinical Trials Planning Meeting (CTPM) for PRO symptom measurement
    • CI-PRO-CTAE for Oncology Committee member