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Why Docuvera > Current/Future Standards

Protocol Modernization & Clinical Acceleration

ICM M11 – USDM – TransCelerate

Structured Authoring for Study Speed, Consistency, and Digital Readiness

The future of clinical documentation is structured, modular, and data-driven. With the advancement of global initiatives such as ICH M11, USDM, and TransCelerate’s Digital Data Flow (DDF), regulators and sponsors are working toward a future where protocol and submission content can be generated once, reused across systems, and exchanged digitally.

Docuvera enables clinical and regulatory teams to author content in a format that aligns with evolving protocol and trial documentation models—without relying on disconnected documents or manual reassembly.

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Supporting Standards for the U.S., E.U. & Across the Globe

Structured Protocols Aligned to ICH M11 / CeSHarP

ICH M11 introduces a globally harmonized structure for clinical protocols—the Clinical electronic Structured Harmonized Protocol (CeSHarP). Its goal: simplify trial startup, reduce downstream rework, and enable digital exchange of protocol elements.

Docuvera allows clinical teams to author protocol components—such as:

Trial objectives and endpoints
Eligibility criteria
Study design and statistical analysis
Arms, visits, and assessments

…as discrete, reusable content blocks that can be mapped to CeSHarP’s template structure and exported for use in downstream systems.

Unified Study Definition Model (USDM) Compatibility

The Unified Study Definition Model (USDM), supported by CDISC, TransCelerate, and FDA, creates a shared logical model for study design across tools and systems.

Docuvera aligns with USDM by:

Structuring protocol elements in alignment with CDISC Study Design standards
Supporting metadata tagging for each study component (e.g., visit windows, endpoint categories, population attributes)
Enabling traceable reuse across protocols, amendments, IBs, and CSRs

TransCelerate Digital Data Flow (DDF) Alignment

The DDF initiative envisions clinical protocols as digital assets that can be written once and reused many times.

Docuvera brings this vision to life by enabling:

Centralized governance of trial components
Reuse of structured content in investigator brochures (IBs), clinical study reports (CSRs), and registry disclosures
Integration with downstream platforms via XML or API

Structured authoring accelerates protocol approval, reduces reconciliation errors, and supports operational reuse from planning through submission.

Accelerating Readiness for Real-Time Review Models

Initiatives such as the FDA’s Real-Time Oncology Review (RTOR) depend on faster content readiness, modular updates, and data-driven submissions.

With Docuvera, clinical and regulatory teams can:

Author once and reuse content across documents and trials
Submit updated components without regenerating full protocols or CSRs
Maintain full traceability across versions, review history, and regulatory interactions

Structured authoring shortens the time between scientific readiness and regulatory submission.

Related Standards & Initiatives Supported by Docuvera

ICH M11 / CeSHarP

Region

Global

Purpose

Standardized, structured clinical protocols

Docuvera Alignment

Enables modular authoring of trial components that map to CeSHarP templates

USDM (Unified Study Definition Model)

Region

U.S. / Global

Purpose

Logical model to support reusable protocol elements across systems

Docuvera Alignment

Aligns structured authoring with USDM objects and metadata

TransCelerate DDF

Region

Global

Purpose

Enables protocol data to be reused and exchanged digitally

Docuvera Alignment

Supports write-once, reuse-many structured content strategy

RTOR (Real-Time Oncology Review

Region

U.S. (FDA)

Purpose

Accelerates review for oncology products through earlier data submission

Docuvera Alignment

Enables modular updates, faster assembly, and version control for critical documents

Business Impact

Organizations using structured content for protocol and clinical authoring workflows benefit from:

Faster protocol approval cycles through modular collaboration
Reduced inconsistency across protocol, IB, and CSR content
Improved alignment with global regulators (FDA, EMA, HC, PMDA)
Digital readiness for DDF, USDM, CeSHarP, and real-time review initiatives

Related Content:

Digital Transformation in Pharma
Regulatory Compliance & Risk Mitigation
Enterprise Governance

Docuvera is here to help you succeed—compliantly, efficiently, and confidently.

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