Life sciences · Regulatory redaction + AI

Clinical document redaction, built for regulatory submissions

iDox.ai automates two-step redaction of CSRs, protocols and safety reports, protects patient (PPD) and commercial (CCI) data, and governs AI use — for FDA, EMA and Health Canada.

Aligned with
EMA Policy 0070Health Canada PRCIFDAHIPAAGDPR

The regulatory way to redact

Two-step redaction, built in

Match the workflow reviewers already trust — propose and justify first, then apply approved redactions.

1Propose & justify

AI suggests — and records why

iDox.ai flags PPD, PHI, CCI and investigator data, and attaches a standardized reason to each redaction.

Patient identifierPPD
Investigator nameInvestigator
Manufacturing detailCCI
2Approve & apply

Reviewers approve — iDox.ai applies

Approved redactions are applied permanently across every page, with an audit-ready certificate generated.

Redactions applied · 77 items
Justification report generated
Certificate ready for submission

Compare

Catch redaction drift before you submit

Every revision risks re-exposing data. Compare any two versions and see exactly what changed.

Clinical doc · V1Clinical doc · V2

152changes spotted

Version 1

Version 2

152

changes spotted

  • Text changed123
  • Text added28
  • Text deleted1

Global transparency

Meet every disclosure requirement

One defensible, audit-ready method across the frameworks that govern clinical disclosure.

EMA Policy 0070

Publish Clinical Study Reports while protecting Protected Personal Data (PPD) and Commercially Confidential Information (CCI) — with justification for every redaction.

Health Canada PRCI

Disclose clinical information under Public Release of Clinical Information — protecting confidential business information and personal data with full audit trails.

FDA & global transparency

Standardize redaction across FDA submissions and clinical trial transparency programs, protecting patient privacy and proprietary research.

Purpose-built AI

Trained on clinical & regulatory language

Not keyword matching — iDox.ai understands the data unique to clinical documents, and lets you add your own compounds and code names.

Patient identifiers (PPD)PHICommercially Confidential (CCI)Subject IDsInvestigator infoDiagnosesAdverse eventsMedications & NDCsLab & measurement valuesCompounds & biomarkers (custom)

AI safety

Keep clinical data out of ChatGPT

  • Let medical writers & researchers use AI — patient and clinical data never leaves.
  • Controls AI-agent actions (e.g. OpenClaw) and blocks unauthorized transfers.
  • Runs on-device, in real time — nothing uploaded.

Built for life sciences

Across the submission lifecycle

Documents we handle

Clinical Study ReportsTrial protocolsInformed consentInvestigator docsSafety & adverse-event reportsPublic disclosure packages

Designed for

Regulatory AffairsMedical writingClinical operationsPharma & biotechCROsCompliance & privacy

FAQ

Life science redaction & AI — FAQs

Submission-ready, faster

Automate regulatory redaction, compare versions, and govern AI — for FDA, EMA and Health Canada.