Medical writing done
in hours — not days.
13 AI modules for every regulatory and scientific writing task — with a trust layer that traces every statement to its source, detects staleness when docs change, and validates ICH E3 compliance per section. Your LLM key, your data, your control.
No data sent to third parties · Your own LLM key · Human review on every output
Latest capabilities
ICH E3 CSR Writer
NewGenerate full Clinical Study Reports section by section — all 10 ICH E3 sections, 50+ pages, with source context injected from your uploaded protocol, SAP, and TLF tables. Export to Word in one click.
Citation Tracing
NewEvery AI-generated statement is anchored to a source document with [N] superscript markers. Hover any marker to see the exact source, section, and supporting quote — full provenance without leaving the page.
Source Staleness Detection
NewUpload a revised protocol or SAP and the platform instantly flags every CSR section that relied on the old document — an orange 'Source Updated' banner appears so nothing slips through.
ICH E3 Section Validation
NewAfter generation, each CSR section gets an automated ICH E3 compliance check — a per-section score, a pass/warn/fail checklist, and a list of specific issues to address before submission.
Every statement traced.
Every section scored.
After the CSR Writer generates a section, two background tasks activate automatically: citation tracing anchors each claim to a source document with superscript markers, and ICH E3 validation scores the section for regulatory compliance. If you later upload a revised protocol, any section that relied on the old version is instantly flagged.
- Citation [N] markers with hover tooltips showing exact source and quote
- ICH E3 section score (0–100) with pass / warn / fail per checklist item
- Orange 'Source Updated' banner when any source document changes
- Manual re-annotate and re-validate buttons on any section
Protocol v3.2 (synopsis) was updated — this section may be outdated. Re-generate or review manually.
This Phase III, randomised, double-blind, placebo-controlled study evaluated Testinib 100 mg once daily in adults with Type 2 Diabetes Mellitus (T2DM).[1] The primary endpoint, change from baseline in HbA1c at Week 26, was met with statistical significance (p<0.001).[2] Safety was consistent with the known profile; no new signals were identified.[3]
ICH E3 Checklist
Sources
13 Modules
Everything a medical writer needs
From first draft to regulatory submission — all in one workspace, built for the way medical writers actually work.
QC Engine
6-category AI quality check — language, scientific, references, data, formatting, compliance — plus deterministic rule engine. Embedded inline in every writer module.
Manuscript Builder
Upload TLF tables → publication-ready clinical narrative in medical writing style. Study-type aware, journal-formatted.
Clinical Study Report
All 10 ICH E3 sections generated with your source docs as context. Citation tracing, ICH E3 validation scores, and source staleness detection on every section.
SLR / Meta-Analysis
PICOS → Boolean search strings → PRISMA flow — end-to-end systematic review with AI screening and data extraction.
Investigator's Brochure
ICH E6 compliant IB for any phase — all 11 sections, version-controlled, submission-ready.
Informed Consent Form
Generate or review ICFs — plain-language, GCP-compliant, multi-region, fully editable.
CTD / Dossier
ICH M4 Module 2 summaries and Module 5 CSRs for NDA, BLA, and MAA submissions.
PSUR / PBRER
ICH E2C(R2) periodic safety reports — signal evaluation, benefit-risk assessment, CIOMS tables.
Clinical Trial Protocol
Full protocols or amendments — ICH E6(R2) compliant, GCP-ready, study design through statistical section.
Slide Decks
Generate CME decks or condense 150–300 slides to target count — with slide map for full audit trail.
Reference & Claim Checker
Map every claim to its citation — flags unsupported statements, partial support, and contradictions before submission.
Submission Pack
Journal-specific formatting, ICMJE checklist, cover letter generator, and ZIP export in the target format.
DSUR
Development Safety Update Reports aligned with ICH E2F — aggregate safety analysis across the development programme.
Workflow
How Learned Writers works
AI generates, the trust layer verifies, you review, workflow approves. Nothing reaches regulators without your sign-off.
Upload your source material
Upload study data, TLF tables, reference PDFs, protocols, or manuscript drafts. Knowledge Sources lets you set org-level documents (SOPs, style guides) that auto-apply across all projects.
AI generates a structured draft
Our AI — powered by your own LLM key (OpenAI, Anthropic, Azure, Gemini, and more) — generates regulatory-aligned content following ICH, FDA, and EMA guidelines, drawing on your source documents as priority context.
Trust layer activates automatically
Citation tracing runs a second pass and anchors every statement to a source document with [N] markers. ICH E3 validation scores the section for compliance. If a source is later revised, affected sections are flagged stale.
Review, approve, and export
Submit for review, get sign-off through the built-in workflow, then download Word, PowerPoint, or Excel — formatted to agency or journal specs.
QC your output before you leave the page
Every writer module embeds a QC panel directly below the generated output. Pick your check categories — language, scientific, regulatory — run the analysis, watch issues stream live, resolve them, and export. No tab-switching. No copy-paste.
- Works on all 13 writer modules
- Pick exactly which categories to check
- Issues stream in real time as the AI checks
- Mark resolved, add comments, then export
QC Analysis — Clinical Study Report
Score: 84/100P-value reported as p<0.05 — exact value required
Missing study limitation disclosure in Section 9.3
Inconsistent tense in Results paragraph 4
Table 3 referenced before Table 2 in text
Your organisation's knowledge, always in context
Upload your SOPs, writing style guides, and regulatory templates once at the workspace level. They become the highest-priority context for every AI generation across all projects — so the AI writes to your standards, not generic ones.
Knowledge Sources
+ Add documentOrg Level — P1
Project Level — P2
Two layers of QC — AI and deterministic rules
LLM checks find nuanced issues — unclear phrasing, statistical gaps, compliance risks. Deterministic rules catch patterns that should always be flagged: missing required sections, overclaim phrases, abbreviation errors, URL citations in text.
Rule Engine
Upload Excel13 built-in rules · Upload custom rules via Excel
Your data never leaves your infrastructure
Connect your own API key from any provider — Anthropic Claude, OpenAI GPT-4o, Azure OpenAI, Google Gemini, Ollama (on-premise), Groq, Bedrock, and more. Every LLM call goes directly from your key to the model. We never see your prompts or outputs.
Aligned with international guidelines
Every module is structured to comply with the relevant ICH, FDA, EMA, CDSCO, and reporting guidelines — so you don't have to start from scratch.
Ready to write faster?
Your admin sets up a workspace in minutes. Log in and start your first CSR section or QC run today — citation tracing and ICH E3 validation run automatically on every output.