Built exclusively for medical writers

Clinical writing,
done in hours —
not days.

Eight AI modules covering every regulatory and scientific writing task — QC, manuscripts, SAP, SAR, protocols, referencing, and evidence mapping. Your LLM key. Your data. Full control.

No data sent to third parties
Human review on every output
Your own LLM key
QC Engine · Live Report
Passed
Overall QC Score
86 /100
Clinical Study Report · v2.1
Language & Clarity
Scientific Accuracy
Reference Integrity
Regulatory Format
3 reference integrity issues flagged
70%
Avg. time saved
vs manual writing
8
AI writing modules
in one workspace
100%
Human-in-the-loop
you review every output
5×
Faster first drafts
with TLF upload
8 Live Modules

Everything a medical writer needs

From quality check to regulatory submission — all in one workspace, built for the way clinical writers actually work.

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Most Used
QC Engine
Document quality check
6-category AI check — language, scientific accuracy, references, data, formatting, and regulatory compliance.
Central QC Engine
Cross-document QC hub
Cross-document QC with study facts, issue tracking, severity scoring, and a unified report across all files.
Manuscript Builder
From data to draft
Upload TLF tables — AI generates publication-ready clinical manuscripts following CONSORT / STROBE / ICMJE.
Statistical Analysis Plan
AI-assisted SAP generation
Generate SAP with endpoint mapping, analysis populations, and statistical methods from your protocol.
Statistical Analysis Results
SAR with QC against SAP
Generate SAR and automatically reconcile results against the approved SAP — flags every deviation.
Clinical Trial Protocol
ICH E6(R2) GCP-ready
Generate full trial protocols or amendments — all ICH E6(R2) sections, GCP-compliant, with version control.
Referencing
Claim-to-citation mapping
Map every claim to its citation, upload reference PDFs as exclusive source, and flag unsupported statements.
Evidence Mapping
Curated evidence base
Curated evidence library for claims, regulatory content, and cross-document referencing — searchable and linkable.
Workflow

How Learned Writers works

A four-step process that keeps you in control — AI assists, the medical writer decides. Nothing reaches regulators without your approval.

1
Upload source material
Study data, TLF tables, reference PDFs, protocols, or raw drafts. PDF, Word, Excel, and PowerPoint supported.
2
AI generates a structured draft
Powered by your own LLM key — Claude, GPT-4o, Gemini, Azure, and more — following ICH, FDA, and EMA guidelines.
3
Review, edit, and approve
Every output opens in a rich-text editor. Human-in-the-loop is non-negotiable — you own every word.
4
Export submission-ready docs
Download Word, PowerPoint, or ZIP packages formatted to journal or agency specifications — ready for QC sign-off.
Bring Your Own LLM

Your data never leaves your infrastructure

Connect your own API key from any provider. Every LLM call goes directly from your key to the model — Learned Machine never stores your prompts or outputs.

Get in touch
Anthropic Claude
Claude 3.5 / Opus
OpenAI GPT-4o
GPT-4o / Turbo
Azure OpenAI
Enterprise deployment
Google Gemini
Gemini 1.5 Pro / Flash
AWS Bedrock
On-cloud managed
Ollama (on-prem)
Fully air-gapped
Groq
Ultra-fast inference
Mistral AI
Open-weight models
Regulatory Compliance

Aligned with international guidelines

Every module is structured to comply with ICH, FDA, EMA, CDSCO, and reporting standards — so you never start from scratch.

ICH E3 (CSR)ICH E6(R2) GCPICH M4 (CTD)ICH E2C(R2) PSURFDA 21 CFR 50EMA GuidelinesCDSCOPRISMA 2020CONSORTSTROBEICMJEVancouver Style
Get in Touch

Request a demo

See Learned Writers in action. Fill in your details and our team will reach out to schedule a personalised walkthrough.

Email us
info@learnedmachine.in
Response time
Within 24 hours

We will reply to info@learnedmachine.in and contact you within 24 hours.

Ready to see it in action?

Contact us at info@learnedmachine.in or use the form above. Our team will schedule a personalised demo for your team.