Powered by DIP AI
Writing X · Medical & Technical Documents
Medical writing. Technical writing. Same engine, same evidence trail.
Built for the people who carry the consequences of every sentence—clinical writers, regulatory leads, and technical authors shipping documents that have to stand up in front of reviewers, auditors, and end users. LLM + retrieval, with an audit-grade citation layer underneath.
1.1 Background
The trial evaluates the efficacy of
AI Suggestion
↳ cites ICH E6(R2) §6.2compound X-217 in adult patients with moderate-to-severe rheumatoid arthritis, building on the Phase IIa results (NCT0XXXXXXX).
Live preview · sample 1 / 5
§ How it works
§ 01 · PROCESS
AI-assisted study design with indication selection, endpoint definition, and inclusion/exclusion criteria—drafted against the ICH E6(R2) framework so the first version is already audit-aware.
Output —→ Audit-ready protocol draft
§ 02 · ANALYSIS
Statistical narrative generation, subgroup analysis, and biomarker correlation in one pass. Every figure carries a traceable citation back to the source dataset and SAP version.
Output —→ Reviewable statistical narrative
§ 03 · REPORT
One-click generation of CSR, Safety Narratives, and Clinical Overviews aligned to ICH E3 and the chosen submission template—US FDA, EMA, or NMPA—with cross-document consistency checks.
Output —→ Submission-ready document set
§ The difference
The Old Way
With Writing X
§ Coverage
Every output is built from the same evidence layer, so cross-document conflicts surface before reviewers see them.
PROTOCOL
Clinical Study Protocol
ICH E6(R2)
CSR
Clinical Study Report
ICH E3
NARRATIVE
Safety Narrative
Per-subject SAE
SAR
Statistical Analysis Report
SAP-aligned
IB
Investigator's Brochure
Annual update
OVERVIEW
Clinical Overview
Module 2.5
AE
AE Summary Tables
MedDRA coded
FDA-SUB
FDA Submission Pack
eCTD ready
§ Under the hood
A retrieval-augmented agent stack tuned on de-identified clinical corpora and aligned with ICH writing conventions. Every claim is grounded to a citable source before it reaches your document.
Fine-tuning happens against your organisation's redacted style memory—your voice, not a generic template.
Evidence trace
3 steps · auditable
SOURCE
NCT04XXXXXX · v3 locked
Clinical dataset
De-identified PFS data, 412 subjects across 27 sites.
ANALYSIS
SAP-aligned · run #128
Statistical output
HR 0.62 (95% CI 0.48–0.79), p < 0.001 vs. standard of care.
DRAFT
CSR §12.3 · auto-cited
Generated sentence
The primary endpoint demonstrated a statistically significant improvement in median PFS [1][2].
Auditable · Versioned · Rebuildable
↗ open trail
§ Compliance
Independently certified across the standards your auditors already trust. Your data stays in your tenancy; training never sees a patient identifier.
§ Finis
Writing X is built for the people who carry the consequences of every sentence—clinical writers, regulatory leads, and technical authors shipping documents that have to stand up in front of reviewers, auditors, and end users alike.
8+
document classes
4
regulatory frameworks
100%
citation-backed claims
0
data leaves tenancy
§ What we draft
§ Frameworks we align to
§ Where it runs
Writing X — medical and technical documents, drafted under audit, signed off in days.
§ End of document