Deterministic regulatory writing

Every sentence in your regulatory documents traces back to source data. Your auditors will ask for it.

TriloDocs drafts regulatory documents with a deterministic, rules-based engine. Numbers are never generated - they are transcribed, verified, and traced.

Built by medical writers, including the former President of EMWA. In production today.

Audit view

Before a draft reaches a writer, every section checks itself against source.

Recreated from an actual TriloDocs run. Each narrative element either resolves to a source table, or it's flagged — nothing in between.

Adverse events
Death Using table 14
Discontinuation Using table 13
Frequency Using table 9
Other Significant Couldn't find tables for Other Significant AEs.
Unresolved items are routed to the author before the draft moves forward - never guessed at.
Architecture

Why it cannot hallucinate your data — by construction, not by prompt.

TriloDocs is two layers with a hard boundary between them. The claim is scoped, testable, and documented — bring your AI governance committee.

Layer 1 — Deterministic Data Engine

Owns every number.

  • Rules-based Python. No probabilistic inference anywhere in the data path.
  • Reads source data directly; values are transcribed, never predicted.
  • Same inputs produce identical outputs, every run. Fully reproducible.
  • Every value passes automated cross-checks against source before it enters a draft.
Layer 2 — Language Layer

Never touches a number.

  • Handles phrasing and readability of narrative text only.
  • Architecturally prevented from generating numerical, statistical, or safety-critical content.
  • All output passes back through Layer 1 verification before it reaches a draft.
The scoped claim: zero hallucination in data processing — guaranteed by architecture, not by model behaviour. This is what makes TriloDocs a GAMP 5 category your QA team can actually validate, unlike probabilistic GenAI systems.
Trust center

Built to survive your IT, QA, and AI governance review.

Everything your review committees need, prepared before they ask for it.

Validation

Validation Accelerator Pack

A complete GAMP 5 documentation suite delivered with your deployment: URS aligned to GxP use cases, IQ/OQ protocols with pre-populated test scripts, traceability matrix mapped to 21 CFR Part 11 and Annex 11, risk and data-integrity assessments. Cuts your validation effort from months to weeks.

Security

Security & Compliance

Deployment models, data residency options for EU clinical data, encryption standards, access controls, audit logging, and our full sub-processor list. Vendor security questionnaires answered from a maintained library — typical turnaround two working days.

AI Governance

Governance Briefing

A briefing written for pharma AI review committees: how the deterministic/LLM boundary is enforced, what the language layer can and cannot produce, and how to evidence it — effectively a pre-drafted internal approval memo for your champion to circulate.

Go to the Trust Centre →
Proof

Tested against human-authored CSRs. It found what they missed.

What the people actually using it say. No anonymous quotes on this site.

Even if I've already written the first draft of the CSR, I would still want to run the data through TriloDocs to check and see if the findings I identified were correct and if I have all the data. It just gives me that peace of mind to know I haven't missed anything.

Senior Director of Medical Writing, top 10 CRO with 10+ years' experience in regulatory medical writing

TriloDocs is built for real medical writing workflows with deep regulatory understanding, not just as another AI tool adapted to generate regulatory documents.

Senior medical writer, 10+ years' experience at a major pharmaceutical company

We compared the TriloDocs output to a final CSR that we had prepared, and TriloDocs found a clinically relevant safety finding that we had overlooked.

Clinical researcher, medium-sized pharmaceutical company

Domain authority

Barry Drees, PhD

Former President of the European Medical Writers Association. Decades of Regulatory documentation authorship across a vast number of submissions. Every rule in the TriloDocs engine encodes regulatory writing practice he has defended in front of agencies — the platform is his expertise, made executable and auditable.

Who it serves

Medical writers first.

TriloDocs drafts; your writers author. The platform produces the verified skeleton — data, tables, traceable narrative — so writers spend their time on interpretation and judgement, not transcription. Adoption comes from the writing team, not around it.

TriloDocs
See TriloDocs in Action

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