Protocols, built intelligently

AI-assisted protocol writing that keeps you in control. From intake to finalization, draft compliant protocols in a fraction of the time.

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Regulatory Intelligence protocol builder interface

Protocol writing, reimagined

AI assists at every step while you remain in complete control of structure and content.

01

AI-Powered Document Structure

Complete an intake form and let AI generate a draft Table of Contents tailored to your study type. Customize sections, reorder, and lock structure before writing begins.

02

Intelligent Reference Management

Upload prior protocols, study documents, and citations. Your files become part of AI memory, informing every draft with your authoritative sources.

03

Section-by-Section Drafting

Write protocols one section at a time with optional AI assistance. AI drafts only when you ask, scoped to your current section—never overwriting your work.

04

Cross-Section Consistency

AI checks alignment between objectives, endpoints, statistics, and schedule of events. Catch conflicts early, maintain regulatory coherence throughout.

How it works

From intake to finalized protocol in three guided steps.

Protocol builder intake and table of contents interface

Step 1

Create your document skeleton

Complete the intake form with study context. AI generates a draft Table of Contents that you can customize, reorder, and lock before writing begins.

  • Intake form captures study type and context
  • AI generates tailored Table of Contents
  • Full control to customize and reorder sections
  • Lock structure before drafting begins
Reference documents and file upload interface

Step 2

Build your knowledge base

Upload reference documents, prior protocols, and citations. These files inform AI suggestions throughout protocol drafting without manual re-entry.

  • Upload PDFs, Word docs, and prior protocols
  • Files become part of AI memory
  • Source-aware drafting from your materials
  • Citations tracked automatically
AI chat assistant for protocol drafting

Step 3

Draft with AI assistance

Write section-by-section with AI available on demand. Ask questions, request drafts, or get consistency checks—always under your control.

  • AI drafts only when you ask
  • Scoped to current section only
  • Cross-section consistency checks
  • No autonomous changes—you approve everything

Built for regulatory teams

Enterprise-grade protocol intelligence without the complexity.

10x
Faster first drafts

Generate structured protocol drafts in hours instead of weeks of manual writing.

1
Platform, full workflow

Intake, synopsis, schedule of events, and protocol drafting unified in one tool.

100%
User control

AI assists only when asked. Every edit requires your approval—no autonomous changes.

Frequently asked questions

How does AI assist with protocol writing?
AI generates draft content only when you explicitly ask. It works section-by-section, never modifying other parts of your document without your approval. You remain in full control of structure, sequencing, and final content.
Can I customize the Table of Contents?
Yes. The AI-generated structure is a starting point. You can add, remove, rename, and reorder sections before locking the structure for drafting. Your customizations override the AI-generated structure.
What file types can I upload as references?
Upload PDFs, Word documents, prior protocols, and other common formats. These become part of your AI knowledge base, informing drafts with your specific source material and regulatory context.
Does the AI write the entire protocol automatically?
No. AI is a writing assistant, not an autonomous author. You control when AI drafts, what it writes, and whether to accept suggestions. No changes are applied without your explicit approval.
How does consistency checking work?
At your request, AI reviews alignment between sections—objectives vs. endpoints, procedures vs. schedule of events—and flags potential conflicts as suggestions. Findings are advisory and require your approval.

Protocol intelligence,
delivered in minutes.

See how Regulatory Intelligence transforms protocol writing with AI assistance that keeps you in control.

Request a demo