The regulatory writing platform for the entire trial lifecycle.
KScribe authors, validates, and keeps every clinical and regulatory document in sync, from protocol to submission. Months of medical writing, delivered in days.
Cumulative exposure and safety experience are drawn from the INTV and SAFE fields.
Adverse event reporting thresholds follow the study's ICH E2A rules.
Nonclinical toxicology summaries are cross-referenced to Module 4.
INTVSAFEICH E6(R3)
Investigator brochure checks · ICH E6(R3) Appendix AWorking
Study schemaUSDM v4.0One study definition. Every document.
Study IDKT-204
Design2-arm RCT
Endpoints1 primary + 4
Eligibility18 criteria
Activities9 visits
Treatment2 arms · QD
EstimandTreatment policy
SafetyICH E2A
Illustrative workflow · Source-linked drafting and connected updates
New: FDA guidance
FDA’s ICH M11 / CeSHarP guidance. A new foundation for clinical protocols.
ICH M11 brings a harmonized protocol template and technical specification. CDISC USDM makes study definitions machine-readable. KScribe connects these foundations to protocol digitization, regulatory authoring, and downstream document updates.
22 May 2026
FDA finalizes ICH M11 (CeSHarP)
Final guidance published in the Federal Register under Docket FDA-2022-D-3054: a guideline, a protocol template, and a technical specification containing harmonized terminologies and standardized data fields for electronic exchange of protocol information.
Protocol structure
ICH M11 / CeSHarP
A harmonized guideline, protocol template, and technical specification define how protocol content is organized and exchanged.
June 2025
CDISC USDM v4.0
The Unified Study Definitions Model, aligned to M11, ships a logical data model, REST API specification, conformance rules, and controlled terminology for machine-readable study definitions.
What it means for a sponsor
Protocol content moves from a formatted document to a defined set of headings, common text, and data fields.
Regulators, ethics committees, and investigators can receive protocol information electronically rather than as a PDF to be re-keyed.
Downstream systems, including EDC, CTMS, registries, and TMF, can consume the study definition directly instead of interpreting prose.
Sponsors still writing protocols as free text face a conversion project before they can exchange them in the standard form.
How KScribe is already built for it
KScribe authors into the study schema first and renders the M11 template from it, rather than reverse-engineering structure out of finished text.
Field structure and terminology follow CDISC USDM v4.0, the reference model aligned to the M11 technical specification.
The schema is exportable as a structured study definition alongside submission-ready Word and eCTD output.
Because every document is bound to the schema, M11 conformance is a property of the source, not a checklist applied at the end.
From startup through submission, KScribe authors the deliverables your teams write today, and keeps them connected.
01Study Startup
5 documents
Synopsis & Feasibility
Concept to design
Protocol
ICH M11 · E6(R3)
Protocol Amendments
Version-controlled
Investigator's Brochure
Clinical and nonclinical
Informed Consent Form (ICF)
Master, country, site
02Trial Conduct
3 documents
Statistical Analysis Plan (SAP)
Estimands and CDISC
Monitoring Documents
Risk-based monitoring
Data Management Documents
DMP and specifications
03Safety & Pharmacovigilance
3 documents
DSUR
ICH E2F annual safety
Safety Narratives
Generated at scale
Development Safety Reports
Periodic safety reporting
04Reporting & Submission
3 documents
Clinical Study Report (CSR)
ICH E3
Submission Package
eCTD-ready modules
eCTD Documents
Cross-referenced modules
90%
faster first-draft creation
20+
document types supported
Days
to submission-ready, not months
100%
source-traceable statements
KScribe writes the entire regulatory record, not one report.
Point tools generate a single deliverable in isolation. KScribe is an enterprise platform that authors and connects every document across the trial, so the whole submission moves as one.
01Source data
Protocol
Previous studies
CSR
SOPs
ICH guidance
Sponsor library
Clinical data
02Study intelligence
Knowledge graphEvidence layer
Study SchemaUSDM v4.0
Design
2-arm RCT
Endpoints
1 primary + 4
Activities
9 visits
03Drafting
[1]
[2]
Source-linked sections Consistent terminology
04Live validation
ICH M11 / CeSHarP
ICH E6(R3)
CDISC / USDM
Terminology
Completeness
Consistency
05Human review
MW
Approved
2 comments
Medical writer review Version & audit trail
06Connected documents
Protocol
Investigator brochure
ICF
SAP
CSR
Submission package
Stages 01 and 02 are protocol digitization: source material is read, normalized, and written into a structured study definition. Everything downstream is generated from it.
One source of truth
Every document drawn from the same study intelligence.
Source documents are digitized into one structured study definition: objectives, endpoints, eligibility, arms, schedule of activities, and safety rules, each held as a field rather than a paragraph. Every deliverable is rendered from it, and every edit is written back to it.
One connected record
Hover any document to see how KScribe keeps it aligned with the rest of the study.
01 Source documents
Concept sheet or synopsis
Previous studies & CSRs
Nonclinical & CMC data
SOPs & ICH guidance
Sponsor library & style guide
ICH M11 template
Extracted, normalized, and mapped to standard fields, not summarized into prose.
02 USDM study schema
4 of 10 consumed
STUDY.ID
Study identification
DESIGN
Design & arms
OBJ.EP
Objectives & endpoints
ELIG
Eligibility criteria
SOA
Schedule of activities
INTV
Interventions & dosing
POP.N
Population & sample size
EST
Estimands & analysis
SAFE
Safety reporting rules
GOV
Governance & oversight
Held as a structured study definition conformant to CDISC USDM v4.0 and the ICH M11 technical specification. The same record your EDC, CTMS, and registry systems can read.
03 Connected documents
Protocol10 fields
Investigator Brochure3 fields
ICF5 fields
SAP4 fields
CSR6 fields
DSUR3 fields
EDC & CRF spec3 fields
Submission Package6 fields
Each document declares the fields it consumes, so its dependencies are explicit and auditable.
An edit anywhere is an edit to the record.
When a writer changes a secondary endpoint in the protocol, the change is written back to the study schema, not to a paragraph. KScribe resolves every document that consumes that field, regenerates the affected sections, and flags what a human needs to approve. Nothing drifts, because there is only one place a fact can live.
01
The edit is captured as a field change
The writer edits in the document; KScribe resolves the edit to the underlying field in the study schema.
02
Dependents are resolved
Every document, section, and system that reads that field is identified from the schema's own dependency graph.
03
Affected sections regenerate
Only the dependent text is rewritten, with the prior version, the trigger, and the rationale retained.
04
Consistency is re-validated
Terminology, cross-references, and numbers are re-checked across the whole set before the change is cleared.
How KScribe works
An authoring pipeline, not a chatbot.
KScribe runs retrieval, drafting, validation, and propagation as a governed pipeline. Every section is grounded in evidence and checked against the rules before a human ever opens it.
01
Digitize
A concept, synopsis, prior data, or sponsor library is read and written into the structured study schema: indication, design, endpoints, eligibility, and regulatory pathway.
02
Ground
Retrieval over ICH guidance, precedent documents, and your evidence base, so every section is grounded in a source.
03
Draft
Standard sections authored from the schema, with inline citations, CDISC tagging, and consistent terminology.
04
Validate
Sections are checked against regulatory rules and internal style before they reach a reviewer.
05
Propagate
Change an endpoint once and KScribe updates the affected sections across linked documents for review.
06
Co-review
Your team comments inline. KScribe regenerates affected sections and retains the version history and audit trail.
Capabilities
Built for the regulated reality of clinical writing.
Structured-first authoring
Documents are rendered from the study schema, so the machine-readable record and the human-readable text can never disagree.
Guideline-aware drafting
ICH, FDA, and EMA conventions are enforced as the document is written, not patched in afterward.
Cross-document consistency
One change updates every linked document. Endpoints, eligibility, and terminology never drift apart.
Source-grounded citations
Every claim traces back to protocol, study data, or guidance, ready for QC and inspection.
Sponsor-library aware
Inhales your past protocols, MOPs, and style guide. Future drafts inherit your terminology and structure.
Version & audit control
Every edit is logged and every draft is reproducible, with a defensible trail from first word to filing.
Regulatory intelligence
Fluent in the standards your filings are judged against.
KScribe authors to current ICH guidance and agency expectations, tags data to CDISC, and assembles output that drops into an eCTD submission, with the reasoning behind every choice on record.
ICH M11 (CeSHarP), E6(R3), E3, and E2C/E2F authoring conventions
CDISC tagging, USDM v4.0 study definitions, and eCTD-ready structure
FDA, EMA, and PMDA submission expectations
ICH M11
Structured protocol
CDISC USDM
Study definition model
ICH E6(R3)
Good Clinical Practice
ICH E3
CSR structure
CDISC
Data standards
eCTD
Submission format
Why KScribe
A different way to produce a submission.
Traditional medical writing
KScribe
Source of truth
The last approved Word file
A structured study schema
First complete draft
Weeks to months
Days
Cross-document updates
Manual reconciliation
Automatic propagation
Citations & traceability
Hand-checked
Source-linked by default
Regulatory alignment
Reviewed after drafting
Validated while writing
Amendments
Cascade of rework
Re-generated downstream
Audit trail
Reconstructed later
Captured continuously
ICH M11 / USDM output
A conversion project
A property of the source
Compliance & security
Enterprise-grade by default. Your data is never used to train models.
KScribe runs in an isolated tenant with full encryption, access controls, and a complete audit log of every action.
No. It removes the blank page and the busywork. Writers move from drafting to directing: setting strategy, reviewing reasoning, and approving the final document.
What is the study schema, and why does it matter?
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It is a structured representation of the study (identification, design, objectives and endpoints, eligibility, schedule of activities, interventions, estimands, and safety rules) held as typed fields rather than prose. KScribe digitizes your source documents into it, generates every deliverable from it, and writes every edit back to it. It is modelled on CDISC USDM and the ICH M11 technical specification, so it is machine-readable by your other clinical systems, not just by KScribe.
Which guidelines and standards does it follow?
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ICH M11 (CeSHarP), E6(R3), E3, and E2C/E2F authoring conventions, CDISC data standards including USDM v4.0, and agency-specific expectations for the FDA, EMA, and PMDA, alongside your own templates and style guide.
How does it use our existing documents?
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KScribe ingests your past protocols, MOPs, and style guide into a private sponsor library. Future drafts inherit your terminology, structure, and review patterns automatically.
Is our data secure?
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Yes. KScribe runs under SOC 2 Type II, HIPAA, and ISO/IEC 27001:2022 controls, in an isolated tenant. Your data is never used to train models.
What formats does it export?
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Submission-ready Word and eCTD-compatible output, plus the structured study definition itself, with citations, tracked changes, and the full audit trail preserved.
How long does it take to get started?
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Most teams author their first draft within days of connecting a sponsor library, with no migration project required.
Bring your next submission forward.
See how KScribe authors your protocol, keeps it aligned with every downstream document, and gets your team to submission-ready faster.