Keep your protocol, consents, and recruitment perfectly aligned 

Keep your protocol, consents, and recruitment perfectly aligned 

Ensure study document alignment before submission to IRBs, sites, or participants.

Ensure study document alignment before submission to IRBs, sites, or participants.

Book a clinical protocol audit agent demo →

Book a clinical protocol audit agent demo →

See a sample alignment review →

See a sample alignment review →

Stop line-by-line comparisons across long documents. 

Stop line-by-line comparisons across long documents. 

Catch risky mismatches in numbers and wording early, not after IRB feedback. 

Catch risky mismatches in numbers and wording early, not after IRB feedback. 

Keep every version of every document tied back to the right protocol or amendment. 

Keep every version of every document tied back to the right protocol or amendment. 

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Clinical Protocol Audit Agent

When manual reviews miss the fine print, compliance risks rise 

When manual reviews miss the fine print, compliance risks rise 

01

01

01

Writers, physicians, and RA/QA teams manage multiple Word or PDF files simultaneously, often under tight deadlines. 

Writers, physicians, and RA/QA teams manage multiple Word or PDF files simultaneously, often under tight deadlines. 

Writers, physicians, and RA/QA teams manage multiple Word or PDF files simultaneously, often under tight deadlines. 

02

02

02

Minor inconsistencies in age ranges, schedules, risks, or compensation can lead to compliance issues. 

Minor inconsistencies in age ranges, schedules, risks, or compensation can lead to compliance issues. 

Minor inconsistencies in age ranges, schedules, risks, or compensation can lead to compliance issues. 

03

03

03

IRBs often return documents with “modifications required,” causing time-consuming rework on protocols, consents, and recruitment materials. 

IRBs often return documents with “modifications required,” causing time-consuming rework on protocols, consents, and recruitment materials. 

IRBs often return documents with “modifications required,” causing time-consuming rework on protocols, consents, and recruitment materials. 

04

04

04

Outdated consents or flyers may circulate during amendments, posing inspection and compliance risks. 

Outdated consents or flyers may circulate during amendments, posing inspection and compliance risks. 

Outdated consents or flyers may circulate during amendments, posing inspection and compliance risks. 

See how clinical protocol audit agent protects →

What are the steps clinical protocol audit agent follows? 

Step 01

Upload Documents

Upload Documents

Share your study protocol, consent forms, and recruitment materials with the Clinical Study Agent.

Share your study protocol, consent forms, and recruitment materials with the Clinical Study Agent.

Step 02

Extract Key Details

Extract Key Details

The agent identifies key information, including objectives, participant criteria, timelines, risks, benefits, and payments.

The agent identifies key information, including objectives, participant criteria, timelines, risks, benefits, and payments.

Step 03

Check Consistency

Check Consistency

Validate consent and recruitment items against the protocol for mismatches or inconsistencies.

Validate consent and recruitment items against the protocol for mismatches or inconsistencies.

Step 04

Review Differences

Review Differences

Your team gets a clear, side-by-side summary of discrepancies for quick fixes and for tracking updates.

Your team gets a clear, side-by-side summary of discrepancies for quick fixes and for tracking updates.

Step 05

Generate Report

Generate Report

The agent compiles a brief report of review findings, corrections, and version history for IRB or audit use.

The agent compiles a brief report of review findings, corrections, and version history for IRB or audit use.

Watch a sample intake flow →

Your AI assistant for study documents 

Your AI assistant for study documents 

Streamline study material review with instant summaries, version checks, and compliance insights. 

Streamline study material review with instant summaries, version checks, and compliance insights. 

Collects every document

Gathers all protocols, consent forms, and recruitment materials by study version.

Extracts key information

Flags mismatches and versions

Collects every document

Gathers all protocols, consent forms, and recruitment materials by study version.

Extracts key information

Captures inclusion criteria, study purpose, procedures, schedules, and participant details.

Flags mismatches and versions

Highlights wording or data inconsistencies and links them to source versions for easy review.

Governance line: Your team stays in control: clinical protocol audit agent suggests what to look at, and people decide what to change and approve. 

Works with what you already use 

Works with what you already use 

Works with what you already use 

Clinical study agent does not replace your CTMS, eIRB, eTMF, or site platforms; it adds an intelligence layer on top of them. That means lower risk for IT and faster time-to-value for business teams. 

Clinical study agent does not replace your CTMS, eIRB, eTMF, or site platforms; it adds an intelligence layer on top of them. That means lower risk for IT and faster time-to-value for business teams. 

Systems

Connects to your CTMS, eIRB, and document systems to pull the latest versions of protocols and consents. 

Works alongside Word, Google Docs, sponsor templates, and site systems, so your team feels supported without workflow disruption. 

Sends status, reports, and alignment notes back into your existing systems so teams can see them in their normal workflows. 

Who uses it

Medical writers and clinical scientists who draft protocols and consents. 

Regulatory affairs and IRB liaisons who prepare submissions and handle “modifications required.” 

Principal investigators and research leaders who sign off on the final content. 

Site staff who rely on clear, consistent documents to explain studies to participants. 

Fewer surprises, faster studies, stronger compliance 

Fewer surprises, faster studies, stronger compliance 

Faster start-up and reconsent

Teams skip manual comparisons, speeding submissions and easing workload.

Fewer IRB comments and delays 

Catch mismatches or discrepancies early to avoid rework and review delays.

Clear proof for audits

Every change is logged for easy traceability with sponsors and regulators.

Less burnout for experts 

Experts focuses on critical decisions, not minor wording checks.

Less site and participant burden

Sites avoid backandforth, and participants get clear, consistent study info.

Governance Mini block 

Clinical study agent helps regulated environments by providing full logging of checkpoints, issue identification, and how they were resolved; all governed by your own rules and review thresholds. 

See examples of reports and dashboards →

Make the protocol the anchor

Make the protocol the anchor

Build trust, consistency, and scale by standardizing what matters most. 

Build trust, consistency, and scale by standardizing what matters most. 

Establishes the approved study protocol (or amendment) as the single source of truth. 

Automatically validates every consent form, flyer, web page, and handout against the latest protocol, no manual checks needed. 

Operates flexibly across modes: live in Word or Google Docs, in bulk from your CTMS, or on a schedule after each amendment. 

Frequently asked questions

Frequently asked questions

Questions teams ask before they turn PA agentic

Does this replace our current systems?

No. Clinical study agent sits on top of your existing tools. You keep using your CTMS, eIRB, and document systems as you do today. Clinical study agent helps them “talk to each other” by checking the content that flows through them.

Does this replace our current systems?

No. Clinical study agent sits on top of your existing tools. You keep using your CTMS, eIRB, and document systems as you do today. Clinical study agent helps them “talk to each other” by checking the content that flows through them.

Will our teams have to change how they work?

Minimal. Your teams keep drafting in familiar tools. Clinical study agent adds a review step that shows exactly where documents disagree and what needs attention.

Will our teams have to change how they work?

Minimal. Your teams keep drafting in familiar tools. Clinical study agent adds a review step that shows exactly where documents disagree and what needs attention.

Who decides what gets changed?

Your people do. Clinical study agent surfaces issues and suggestions, but only your staff edits documents and gives final approval.

Who decides what gets changed?

Your people do. Clinical study agent surfaces issues and suggestions, but only your staff edits documents and gives final approval.

How does this help with amendments?

Whenever the protocol changes, Clinical study agent can scan all related consents and recruitment materials and highlight which ones need to be updated.

How does this help with amendments?

Whenever the protocol changes, Clinical study agent can scan all related consents and recruitment materials and highlight which ones need to be updated.

Can this work alongside our protocol and consent builders?

Yes. Clinical study agent complements existing authoring and site tools by providing deep cross-document checks that they don't offer.

Can this work alongside our protocol and consent builders?

Yes. Clinical study agent complements existing authoring and site tools by providing deep cross-document checks that they don't offer.

Is our data protected?

Yes. Clinical study agent runs in a secure environment with tight access controls and detailed logs, aligned with clinical research and privacy expectations.

Is our data protected?

Yes. Clinical study agent runs in a secure environment with tight access controls and detailed logs, aligned with clinical research and privacy expectations.

Ready to see where your documents don’t match before the IRB does?

Ready to see where your documents don’t match before the IRB does?

Learn how the elsai clinical protocol audit agent enhances accuracy, accelerates review, and boosts IRB and audit readiness, no system changes needed. 

Learn how the elsai clinical protocol audit agent enhances accuracy, accelerates review, and boosts IRB and audit readiness, no system changes needed. 

elsai

Enterprise AI governance platform for agentic workflows. Transform your operations with confidence.

Offices

USA

UK

Australia

UAE

India

© 2026 elsai. All rights reserved.

elsai

Enterprise AI governance platform for agentic workflows. Transform your operations with confidence.

Offices

USA

UK

Australia

UAE

India

© 2026 elsai. All rights reserved.

elsai

Enterprise AI governance platform for agentic workflows. Transform your operations with confidence.

Offices

USA

UK

Australia

UAE

India

© 2026 elsai. All rights reserved.

elsai

Enterprise AI governance platform for agentic workflows. Transform your operations with confidence.

Offices

USA

UK

Australia

UAE

India

© 2026 elsai. All rights reserved.