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SCOPE Summit for Clinical Ops Executives

Panel AI for Clinical Trials · Data · Real World Evidence

Transforming the Clinical Trial Protocol—Moving from a Document-Centric to a Data-Centric World

Thu, Feb 6, 2025 · 12:25–1:25 PM EST Rosen Shingle Creek

About this session

Panel Discussion.

Since the beginning, the industry has been writing and copying protocols in Word while manually transcribing protocol information to the plethora of downstream systems, which is time-consuming, error-prone, and questions quality. Over the last few years, the industry has been working on moving from a document-centric to a data-centric protocol, helping industry reduce cycle times and improve data reliability and quality for sponsors, third party providers, and regulators. This panel will bring together TransCelerate, CDISC, HL7, and ICH M11 to discuss the current state of the digital protocol and the opportunities to transform the clinical trial lifecycle.

Speakers

  • Chris Decker

    President & CEO · CDISC

    Moderator

  • Amy Cramer

    Vulcan Founder; Director Data Acquisition-eSource · Johnson and Johnson Innovative Medicine

    Panelist

  • Stacy Tegan

    Program Director · TransCelerate Biopharma Inc

    Panelist

  • Mary Lynn Mercado

    Global Head Protocol Delivery & US Site Head · Novartis Pharmaceuticals

    Panelist

  • Donald Jennings

    Sr. Director · Eli Lilly & Co

    Panelist