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Virtual

Breaking the Protocol Bottleneck: Digital Transformation with CDISC USDM and Structured Authoring

Discover how Docuvera and Open Study Builder accelerate study startup by automating ICH M11 protocol generation through CDISC USDM and Digital Data Flow integration.

Overview

This on-demand Solution Provider Webinar is brought to you by DIA in cooperation with

This webinar explores how the integration of Open Study Builder (OSB) with Docuvera transforms clinical trial protocol development through automation, interoperability, and digital data flow. The joint solution addresses the legacy challenges of lengthy approval cycles and high startup resource requirements by moving from a document-centric to a data-centric paradigm. Attendees will see how CDISC USDM and TransCelerate DDF frameworks enable real-time synchronization between study design and protocol authoring. The session will demonstrate automated ICH M11-compliant protocol generation, component-based authoring, and FHIR export for seamless regulatory data exchange.

Featured topics

  • Overcoming inefficiencies in clinical study startup and protocol approval
  • Integrating Open Study Builder (OSB) with Docuvera for end-to-end digital workflows
  • Automating ICH M11-compliant protocol generation using CDISC USDM standards
  • Leveraging TransCelerate DDF frameworks for real-time interoperability
  • Enabling data-driven authoring with FHIR export for regulatory compliance
  • Case study: Seamless transition from structured study design to protocol generation

Who should attend?

Professionals who work in the area of:

  • Clinical Operations and Study Start-Up
  • Regulatory Affairs and Submissions
  • Clinical Data Management and Standards
  • Digital Transformation and Technology Enablement
  • Clinical Systems and IT Integration
  • Clinical Development Leadership

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