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.
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
| Initiative | Region | Purpose | Docuvera Alignment |
| ICH M11 / CeSHarP | Global | Standardized, structured clinical protocols | Enables modular authoring of trial components that map to CeSHarP templates |
| USDM (Unified Study Definition Model) | U.S. / Global | Logical model to support reusable protocol elements across systems | Aligns structured authoring with USDM objects and metadata |
| TransCelerate DDF | Global | Enables protocol data to be reused and exchanged digitally | Supports write-once, reuse-many structured content strategy |
| RTOR (Real-Time Oncology Review | U.S. (FDA) | Accelerates review for oncology products through earlier data submission | 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