Solution

Clinical Protocol Validator

For medical writers, protocol authors and clinical operations at sponsors and CROs: draft protocols stress-tested against guidance, SOPs and their own tables before a patient is enrolled.

Study protocolsSchedule of AssessmentsFDA/EMA guidanceInternal SOPsEligibility criteria

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Errors caught at design time, before enrollmentEvery finding cited to guidance, SOP or the conflicting sectionThe validator proposes; medical writers decide

The problem

Why this exists

~$500k

The cost of one amendment

A substantial protocol amendment costs months of study delay — and most amendments trace back to inconsistencies sitting in the initial document all along.

Visit 3

Tables that contradict the text

A lab test sits in the Schedule of Assessments but never appears in the visit description. Sites find it after activation.

Per site

Eligibility read differently everywhere

A criterion like uncontrolled hypertension means something different at every site. Screen failures and queries follow.

The product, not a promise

A protocol draft you can interrogate

Clinical Protocol Validator — workspace

Schedule of Assessments vs. visit textReconciled · table ↔ textcited

Eligibility criteriaTested · patient pathways simulatedcited

FDA/EMA guidance mapEndpoints + safety language checkedcited

Site & patient burdenPer-visit intensity scoredcited

Subjective criterion "stable medication" — quantifiable wording proposed for writer reviewverify

HUMAN-APPROVED BEFORE IT POSTS

How it works

File in. Answer out.

Who it's for

Built for the people who own the outcome

Medical writer

Findings you can verify, attached to the draft.

Every flag cites the guidance paragraph, SOP clause or conflicting section
Subjective wording comes with proposed quantifiable replacements
A live view of what remains inconsistent as you iterate

Head of clinical development

Protocols that execute the first time.

Amendment drivers caught upstream of enrollment
Site and patient burden visible at design time
Fewer site queries and screen failures downstream

QA & regulatory affairs

Review history that stands up to inspection.

Findings, dispositions and revisions logged with the document
Draft mapped against current FDA/EMA guidance and your SOPs
IRB/EC and audit questions answered from the record

Pharma sponsorsBiotechsCROsMedical device trialsAcademic research organizations

Six figurestypical cost of one amendment

100%findings traced to source standards

Pre-enrollmenterrors caught at design time

Writer-decidedthe validator proposes, humans dispose

A protocol amendment costs close to $500,000 and months of study delay — and most amendments trace back to inconsistencies that were sitting in the initial document all along. A lab test listed in the Visit 3 column of the Schedule of Assessments but missing from the Visit 3 text. An eligibility criterion like “uncontrolled hypertension” that every site interprets differently. Safety language a recent FDA or EMA guidance expects that the draft never picked up.

Four classes of error, caught upstream

The Clinical Protocol Validator reads draft protocols in Word or PDF and stress-tests the logic before a single patient is enrolled:

Internal consistency — cross-references the synopsis, body text, footnotes, and the Schedule of Assessments, flagging procedures that appear in a table but not in the visit description, and vice versa.
Eligibility precision — detects subjective inclusion and exclusion wording and suggests quantifiable replacements, such as no dose change in the last 30 days instead of stable medication.
Regulatory alignment — maps the draft against current FDA/EMA guidance and therapeutic-area frameworks to confirm required endpoints and safety language are present.
Site and patient burden — scores procedural intensity per visit, so heavy visits that threaten recruitment and retention are visible at design time.

Findings with full traceability

Every finding cites its source — the guidance paragraph, the SOP clause, or the conflicting section of the protocol itself — so medical writers can verify the issue rather than take the system’s word for it. Flags route to the writing team for structured review; the validator proposes, humans decide. Teams iterate on the draft with a live view of what remains inconsistent, ambiguous, or non-compliant, and the review history stays attached to the document for IRB/EC and audit purposes.

The result is a protocol that is executable the first time: fewer preventable amendments, fewer site queries, and an approval process that starts from a clean document.

Objections, answered

What teams ask us first

How do I trust a finding?

Every finding cites its source — the guidance paragraph, the SOP clause, or the conflicting section of the protocol itself — so a medical writer verifies the issue at the source rather than taking the system's word for it. Findings are proposals; the writing team decides each disposition, and that decision is logged.

Can it check against our SOPs and therapeutic-area standards?

Yes. The validator maps drafts against your internal SOP library and therapeutic-area frameworks alongside current FDA/EMA guidance. Your standards library is loaded once, versioned, and maintained by your team.

What survives for IRB/EC and audit?

The full review history stays attached to the document: every finding, its citation, who reviewed it, and how it was resolved across revisions. Access is role-based and every action is logged, so the design-review trail is inspectable end to end.

How long before a first validated draft?

The validator reads Word or PDF drafts as they are — no document preparation or reformatting. The setup work is loading your SOPs and guidance set; a current draft can be run and its findings reviewed as soon as that library is in place.

Bring your current draft protocol.

Watch it reconcile the Schedule of Assessments, test the eligibility logic and map guidance gaps — live on your document.

Request a demo