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Clinical protocol audit agent
Keep your protocol, consents, and recruitment aligned
Discover how the clinical protocol agent safeguards your trials. Ensure document alignment before submission to IRBs, sites, or participants.
Keep your protocol, consents, and recruitment aligned
Discover how the clinical protocol agent safeguards your trials. Ensure document alignment before submission to IRBs, sites, or participants.
Eliminate tedious line-by-line comparisons in lengthy documents.
Eliminate tedious line-by-line comparisons in lengthy documents.
Identify discrepancies in numbers and wording early, before IRB feedback.
Identify discrepancies in numbers and wording early, before IRB feedback.
Link every document version to the relevant protocol or amendment.
Link every document version to the relevant protocol or amendment.
When manual reviews miss the fine print, compliance risks rise
When manual reviews miss the fine print, compliance risks rise
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Writers, physicians, and RA/QA teams manage multiple Word or PDF files simultaneously, often under tight deadlines.
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Writers, physicians, and RA/QA teams manage multiple Word or PDF files simultaneously, often under tight deadlines.
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Writers, physicians, and RA/QA teams manage multiple Word or PDF files simultaneously, often under tight deadlines.
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Minor inconsistencies in age ranges, schedules, risks, or compensation can lead to compliance issues.
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Minor inconsistencies in age ranges, schedules, risks, or compensation can lead to compliance issues.
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Minor inconsistencies in age ranges, schedules, risks, or compensation can lead to compliance issues.
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IRBs often return documents with “modifications required,” causing time-consuming rework on protocols, consents, and recruitment materials.
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IRBs often return documents with “modifications required,” causing time-consuming rework on protocols, consents, and recruitment materials.
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IRBs often return documents with “modifications required,” causing time-consuming rework on protocols, consents, and recruitment materials.
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Outdated consents or flyers may circulate during amendments, posing inspection and compliance risks.
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Outdated consents or flyers may circulate during amendments, posing inspection and compliance risks.
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Outdated consents or flyers may circulate during amendments, posing inspection and compliance risks.
What steps does the clinical protocol audit agent follow?
What steps does the clinical protocol audit agent follow?
Step 01
Upload your documents
Share your study protocol, consent forms, and recruitment materials with the clinical protocol agent.
Step 01
Upload your documents
Share your study protocol, consent forms, and recruitment materials with the clinical protocol agent.
Step 02
Extract key information
Highlight study details like objectives, participant criteria, timelines, risks, benefits, and payments.
Step 02
Extract key information
Highlight study details like objectives, participant criteria, timelines, risks, benefits, and payments.
Step 03
Verify consistency
Verify that consent and recruitment details match the protocol, noting any gaps or mismatches.
Step 03
Verify consistency
Verify that consent and recruitment details match the protocol, noting any gaps or mismatches.
Step 04
Review and compare
Quick, side-by-side summary of differences for easy corrections and version tracking.
Step 04
Review and compare
Quick, side-by-side summary of differences for easy corrections and version tracking.
Step 05
Generate a summary report
Concise report of findings, updates, and version history ready for IRB submission or audit.
Step 05
Generate a summary report
Concise report of findings, updates, and version history ready for IRB submission or audit.
Your AI assistant for protocol documents
Streamline protocol review with instant summaries, version checks, and compliance insights.
Your AI assistant for protocol documents
Streamline protocol review with instant summaries, version checks, and compliance insights.
Collects and organize all documents
Protocols, consent forms, and recruitment materials, and versions.
Extracts key protocol information
Flags mismatches for easy review.
Collects and organize all documents
Protocols, consent forms, and recruitment materials, and versions.
Extracts key protocol information
Includes criteria, purpose, procedures, schedules, and participant details.
Flags mismatches for easy review.
Highlights wording or data inconsistencies, along with source versions
Governance: Your team stays in control. The clinical audit agent flags review areas, while changes and approvals remain with you.
Governance: Your team stays in control. The clinical audit agent flags review areas, while changes and approvals remain with you.
Works with your existing systems, not against them.
Clinical protocol agent enhances your CTMS, eIRB, eTMF, and site tools, reducing IT risk and accelerating time-to-value.
Works with your existing systems, not against them.
Clinical protocol agent enhances your CTMS, eIRB, eTMF, and site tools, reducing IT risk and accelerating time-to-value.
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.
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.
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.
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
Clinical protocol agents ensure compliance by logging checkpoints, flagging issues, and documenting resolutions according to your defined rules.
Governance
Clinical protocol agents ensure compliance by logging checkpoints, flagging issues, and documenting resolutions according to your defined rules.
Make protocol the anchor
Build trust, consistency, and scale by standardizing priorities.
Make protocol the anchor
Build trust, consistency, and scale by standardizing priorities.
Sets the approved study protocol as the single source of truth
Sets the approved study protocol as the single source of truth
Automatically validates all materials against the latest version without manual review
Automatically validates all materials against the latest version without manual review
Works across Word, Google Docs, CTMS, or runs automatically after each amendment
Works across Word, Google Docs, CTMS, or runs automatically after each amendment
Embed AI agents into your existing systems
Seamlessly integrate AI agents into your current platforms to elevate capabilities, optimize workflows, and accelerate innovation.
Frequently asked questions
Questions leaders ask before turning HealthScribe on
Frequently asked questions
Questions leaders ask before turning HealthScribe on
Our team spends days on manual line-by-line document comparisons. What does the clinical protocol audit agent actually check?
The agent automatically cross-checks your protocol, consent forms, and recruitment materials for mismatches in participant criteria, age ranges, timelines, risks, compensation, and wording — flagging every discrepancy before your team submits to an IRB or site. Teams spend less time comparing documents manually and more time resolving actual issues.
Our team spends days on manual line-by-line document comparisons. What does the clinical protocol audit agent actually check?
The agent automatically cross-checks your protocol, consent forms, and recruitment materials for mismatches in participant criteria, age ranges, timelines, risks, compensation, and wording — flagging every discrepancy before your team submits to an IRB or site. Teams spend less time comparing documents manually and more time resolving actual issues.
IRBs keep returning our submissions with "modifications required." Can this agent catch those issues before we submit?
Yes. The agent validates consent and recruitment documents against the approved protocol before submission — surfacing the exact discrepancies in numbers, wording, or structure that trigger IRB comments. Catch the mismatch in-house, not in the IRB feedback letter.
IRBs keep returning our submissions with "modifications required." Can this agent catch those issues before we submit?
Yes. The agent validates consent and recruitment documents against the approved protocol before submission — surfacing the exact discrepancies in numbers, wording, or structure that trigger IRB comments. Catch the mismatch in-house, not in the IRB feedback letter.
When we amend a protocol, how do we know which consent forms, recruitment flyers, and site documents need updating?
After every amendment, the agent automatically scans all related documents and flags every item that no longer aligns with the updated protocol. You get a structured impact report showing exactly what changed and what needs to be revised — before outdated versions circulate to sites or participants.
When we amend a protocol, how do we know which consent forms, recruitment flyers, and site documents need updating?
After every amendment, the agent automatically scans all related documents and flags every item that no longer aligns with the updated protocol. You get a structured impact report showing exactly what changed and what needs to be revised — before outdated versions circulate to sites or participants.
How much does the AI decide on its own? Our regulatory team needs to stay in control of all document changes.
elsai identifies and prioritizes issues, but your team retains full control over document changes and approvals. Every change remains with your medical writers, regulatory affairs, and PI. The agent gives your team a complete, prioritised list of what to fix; your team decides what action to take.
How much does the AI decide on its own? Our regulatory team needs to stay in control of all document changes.
elsai identifies and prioritizes issues, but your team retains full control over document changes and approvals. Every change remains with your medical writers, regulatory affairs, and PI. The agent gives your team a complete, prioritised list of what to fix; your team decides what action to take.
We face sponsor audits and FDA inspections. Is every document review and finding logged in a defensible, audit-ready format?
Yes. Every check, flag, version comparison, and resolution is logged with a full audit trail — timestamped, linked to the document version, and tied to the governance rule applied. Your compliance team gets inspection-ready evidence without reconstructing anything after the fact.
We face sponsor audits and FDA inspections. Is every document review and finding logged in a defensible, audit-ready format?
Yes. Every check, flag, version comparison, and resolution is logged with a full audit trail — timestamped, linked to the document version, and tied to the governance rule applied. Your compliance team gets inspection-ready evidence without reconstructing anything after the fact.
Ready to see your document mismatches before the IRB does?
Discover how elsai’s clinical protocol audit agent enhances accuracy, speeds up reviews, and ensures IRB and audit readiness without any system changes.
Ready to see your document mismatches before the IRB does?
Discover how elsai’s clinical protocol audit agent enhances accuracy, speeds up reviews, and ensures IRB and audit readiness without any system changes.
elsai
Enterprise AI governance platform for agentic workflows. Transform your operations with confidence.
elsai
Enterprise AI governance platform for agentic workflows. Transform your operations with confidence.
elsai
Enterprise AI governance platform for agentic workflows. Transform your operations with confidence.
elsai
Enterprise AI governance platform for agentic workflows. Transform your operations with confidence.