Medical writing,
done in hours — not days.
Learned Writers gives you 12 AI modules for every regulatory and scientific writing task — QC, CSR, SLR, IB, ICF, CTD, PSUR, protocols, manuscripts, and more. Your LLM key, your data, your control.
No data sent to third parties · Your own LLM key · Human review on every output
12 Writing 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
Manuscript Builder
Upload TLF tables → publication-ready clinical narrative in medical writing style
Clinical Report (CSR)
All ICH E3 sections, patient narratives, TLF interpretation, protocol/SAP QC
SLR / Meta-Analysis
PICOS → Boolean search → PRISMA flow — end-to-end systematic literature review
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
CTD / Dossier
ICH M4 Module 2 summaries and Module 5 CSRs for NDA/BLA/MAA submissions
PSUR / PBRER
ICH E2C(R2) periodic safety reports — signal evaluation, benefit-risk assessment
Clinical Trial Protocol
Generate full protocols or amendments — ICH E6(R2) compliant, GCP-ready
Slide Decks
Generate CME decks or condense 150–300 slides with full audit trail
Claim Checker
Map every claim to its citation — flags unsupported statements before submission
Submission Pack
Journal-specific formatting, cover letter, ICMJE checklist, and ZIP export
Workflow
How Learned Writers works
A four-step process that keeps you in control at every stage — AI assists, humans decide.
Upload your source material
Upload study data, TLF tables, reference PDFs, protocols, or raw manuscript drafts. We support PDF, Word, Excel, and PowerPoint.
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.
You review, edit, and approve
Every output goes to a rich text editor for your review. Nothing is sent to regulators without your approval. Human-in-the-loop is non-negotiable.
Export submission-ready documents
Download Word, PowerPoint, or ZIP packages formatted to journal or agency specifications — ready for your QC sign-off.
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.
From the Field
What medical writers say
"Cut our CSR first-draft time from 2 weeks to 2 days. The ICH E3 structure is spot-on and the QC engine catches things we used to miss."
Senior Medical Writer
Global CRO
"The SLR module alone saves us weeks. From PICOS to PRISMA in one guided workflow — our literature team uses it on every project now."
Head of Evidence Synthesis
Medical Affairs Agency
"We were sceptical about AI for regulatory content, but the BYOLLM model means our data never leaves our own Azure environment. That was the dealbreaker for us."
VP Regulatory Affairs
Mid-size Pharma
Ready to write faster?
Your admin can set up your workspace in minutes. Log in and start your first QC run or manuscript draft today.