Clinical study protocols, built intelligently

AI-assisted protocol writing that keeps you in control. From intake to finalization, generate study-specific outlines, protocol synopsis, schedule of activities, and review-ready sections in a fraction of the time.

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Protocols product protocol builder interface

Clinical protocol writing, reimagined

AI assists at every step while you remain in complete control of structure, section drafting, and final review.

01

Study-Specific Protocol Structure

Complete an intake form and let AI generate a draft Table of Contents tailored to your study type. Build the protocol synopsis, outline, and supporting sections from a structure that matches the study you are actually running.

02

Source-Grounded Reference Management

Upload prior protocols, study documents, SAPs, and citations. Your files become part of AI memory, informing every draft with your authoritative sources and reducing manual copy-forward work.

03

Review-Ready Section Drafting

Write protocols one section at a time with optional AI assistance. AI drafts only when you ask, scoped to your current section, so teams can move toward review-ready text without losing control.

04

Cross-Section Protocol Consistency

AI checks alignment between objectives, endpoints, statistics, synopsis details, and schedule of activities. Catch conflicts early and reduce review cycles before the draft goes out.

How it works

From intake to a review-ready clinical study protocol in three guided steps.

Protocol builder intake and table of contents interface

Step 1

Generate a study-specific protocol outline

Complete the intake form with study context. AI generates a draft Table of Contents that you can customize, reorder, and lock before writing begins, giving you a faster path to protocol synopsis and schedule of activities drafting.

  • Intake form captures study type and context
  • AI generates tailored Table of Contents
  • Protocol synopsis and schedule of activities start from the same structure
  • 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, SAPs, and citations. These files inform AI suggestions throughout protocol drafting without manual re-entry.

  • Upload PDFs, Word docs, prior protocols, and SAPs
  • 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 review-ready drafts, or run consistency checks before the document goes out for team review.

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

Built for protocol teams

Enterprise-grade protocol writing support for faster drafting and fewer review-cycle surprises.

10x
Faster first drafts

Generate structured clinical protocol drafts and review-ready sections in hours instead of weeks of manual writing.

1
Platform, review-ready workflow

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

100%
User control

AI assists only when asked. Every edit requires your approval, so teams can move faster without losing authorship.

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, SAPs, and other common formats. These become part of your AI knowledge base, informing drafts with your specific source material and regulatory context.
Can it help with protocol synopsis and schedule of activities drafting?
Yes. The platform can use your intake details and source documents to help structure and draft protocol synopsis content and schedule of activities sections, while keeping every suggestion reviewable and under your control.
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 Unobio Protocols transforms clinical protocol writing with AI assistance that keeps you in control and helps reduce review cycles.

Request a demo