Protocol Errors Do Not Belong in Your Trial.
Detect inclusion/exclusion contradictions, PHI risks, and trial registry discrepancies before ethics committees do.
A contradiction between inclusion and exclusion criteria hidden in Section 5.2. A subject ID that survived de-identification in an adverse event report. A registry number that fails to resolve on ClinicalTrials.gov. In clinical research, these are major protocol amendments and compliance incidents. Keoplan detects them at the document level before they reach regulatory bodies.
Hidden Risks Lurking in Protocol Documentation
Each of these vulnerabilities can delay, block, or compromise your trial.
Inclusion / Exclusion Contradictions
Clinical trial protocols often contain subtle contradictions between eligibility sections—a minimum age in one clause colliding with a pediatric exclusion in another. Keoplan flags these logic conflicts automatically.
Unredacted PHI in Shared Documents
Participant names, hospital identifiers, and birth dates frequently survive document redaction. A single unredacted field shared externally is a GDPR/HIPAA violation. Keoplan scans and highlights all remaining identifiers.
Trial Registry Discrepancies
ClinicalTrials.gov, DRKS, ISRCTN, and EudraCT entries drift as protocols evolve. Keoplan validates trial registration IDs in context and flags parameter mismatches.
Multilingual Protocol Translation Overhead
Sponsors operating in EU markets need protocols, informed consent forms, and patient information sheets translated accurately into German without introducing dosing ambiguities or losing clinical precision.
Engineered for Clinical Trial Demands
Protocol Logic Audit
Automated cross-checking of inclusion/exclusion criteria, endpoint definitions, and dose escalation schedules within the same document.
PHI De-identification Scanner
Scans documents for remaining personal data: participant names, subject IDs, birth dates, facility names, and investigator contacts.
Trial Registry ID Validation
Extracts NCT, DRKS, ISRCTN, and EudraCT identifiers from text and validates them against external registry entries.
Informed Consent Form Translation
Translate Patient Information Sheets and Consent Forms from English to German with lay-language tuning.
Audit Log & Version History
Every document processed is logged with timestamp, audit findings, and reviewer sign-off.
Human Expert Reviewer Sign-off
Route protocol translations through Dr. Keogh’s specialist review layer for qualified second-opinion sign-off.
From Draft Protocol to Audit-Ready Package
Upload your Clinical Trial Protocol, ICF, or Patient Information Sheet (DOCX or PDF)
Keoplan executes logic audit: cross-checking eligibility criteria, endpoints, and registry IDs
PHI scanner runs automatically—highlighting any remaining identifiers with location and type
Audit report generated with section-level findings
Optional: Translate document to German with clinical precision and lay-language options
Download your certified, audit-ready document package
Supported Registries & Standards
Make Protocol Errors a Thing of the Past.
Clinical research teams across Europe trust Keoplan to validate, de-identify, and translate trial documentation.
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