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

12/2/2025 9 AM ET/3 PM CET

 

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Overview:

Clinical trials are often slowed by manual, document-based processes, redundant authoring, and fragmented data systems, leading to long protocol approval cycles and compliance risks. The Open Study Builder (OSB)–Docuvera integration addresses these challenges by transforming protocol creation from a document-centric to a data-centric workflow. Leveraging CDISC USDM and TransCelerate Digital Data Flow (DDF) standards, the solution enables real-time data exchange, automated ICH M11-compliant protocol generation, and FHIR export for regulatory use. This seamless, structured approach accelerates study startup, improves consistency, and reduces operational burden across the clinical trial lifecycle.

 

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

Speakers:

 

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Murali Menon

Chief Revenue Officer, Docuvera

Murali Menon is Chief Revenue Officer at Docuvera, where he leads business strategy and partnerships focused on transforming how life sciences organizations create, manage, and deliver clinical and regulatory content. With over 20 years of experience in technology and digital transformation, Murali is passionate about helping teams move from document-based to data-driven processes. His leadership combines deep domain expertise with a vision for interoperability, automation, and compliance across the clinical lifecycle.

 

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Katja Glass

Owner and Open Source Ambassador, Katja Glass Consulting 

Katja Glass is an open-source advocate dedicated to fostering collaboration and innovation within the pharmaceutical and life sciences industries. Through her work, she champions open-source solutions that enhance transparency, interoperability, and shared learning across organizations. Passionate about technology and community-driven development, Katja focuses on enabling the adoption of open frameworks that advance scientific progress and accelerate digital transformation.