FDA · EMA · ICH E6 (R3)

Eliminate Submission Delays. Automated FDA & ICH Compliance Auditing for Microsoft Word.

The secure, downloadable PWA engineered for Clinical Operations. Cross-reference trial database metrics, fix corrupted Word XML hierarchies, and audit documents locally in your browser before regulatory submission.

Request Institutional Demo
No document upload US · UK · EU deployments 21 CFR Part 11 aligned
ClinOpsWord workspace auditing a clinical trial protocol with highlighted compliance issues

Document Health Index

72/100

The $8M Operational Problem

Every delayed submission burns roughly $8M in lost market exclusivity.

Three failure modes account for the overwhelming majority of avoidable regulatory rework in Phase II and Phase III programmes.

Data Integrity

Data Discrepancies

Patient counts in Section 4.2 disagree with the adverse event tables. Alpha levels drift from the SAP. Each unresolved numeric conflict becomes a regulatory information request and weeks of submission delay.

63% of RFIs trace to numeric inconsistency

Word XML

Style & XML Corruption

Blacked-out bullet numbers, tables of contents frozen at revision 7, and bloated 40MB templates that crash editing teams mid-review cycle across three continents.

Avg. 180 corrupt style references per CSR

Sovereignty

Sovereign Data Security

Unreleased drug formulas and unblinded safety data must never leave the local machine or touch an unvetted cloud vendor. Most SaaS auditors fail this requirement on day one of vendor review.

Zero bytes transmitted during analysis

Local Sandbox Mode: Active (Data Secured Locally)

Zero Data Leaves Your Device.

ClinOpsWord installs as a Progressive Web App and executes tokenization, .docx unzipping, WordprocessingML parsing and cross-reference analysis entirely inside the browser's sandbox environment. Your protocol never crosses a network boundary — which is what makes total HIPAA and GDPR compliance achievable without an external server risk surface, vendor security review, or a new data processing agreement.

Open the workspace

No server transfer

Files are read via the File System Access API and held in memory only.

In-browser parsing

Tokenization and XML repair run in a sandboxed worker thread.

Offline-ready install

Runs as a desktop-class window with no IT deployment package.

Audit trail locally

Findings are exportable as a validated evidence report you control.

Enterprise Waitlist

Institutional access for clinical operations teams.

Validated deployments are onboarded in cohorts by region. Tell us about your programme and our regulatory solutions architects will schedule a walkthrough with your submission team.

  • Validation pack: IQ/OQ documentation and 21 CFR Part 11 mapping
  • Sponsor-side SSO and invite-only corporate access codes
  • Cross-reference connectors for ADSL, ADAE and SDTM exports

Submissions are stored securely for enterprise onboarding only. No document content is ever transmitted.