A secure, local-first layer for clinical operations teams. ClinOpsWord audits Microsoft Word protocols and CSRs inside your browser sandbox — so no trial document crosses a network boundary on its way to FDA, EMA or ICH E6 submission.
Why teams need a different research tool
Most clinical research software routes protocols and CSRs through shared infrastructure. That means vendor security reviews, data-processing agreements, and data-residency assessments before teams can start auditing.
CTMS, eTMF and RIM platforms manage metadata and workflows, but the .docx files regulators open can still contain corrupted numbering, broken cross-references, and drifting styles that trigger information requests.
When studies run across FDA, EMA and Health Canada jurisdictions, a single cloud region rarely satisfies every sponsor's governance model, and multi-tenant access becomes a recurring audit concern.
ClinOpsWord installs as a Progressive Web App and runs every audit locally: tokenization, .docx unzipping, WordprocessingML parsing and cross-reference analysis happen inside your browser. That architecture makes total HIPAA and GDPR alignment possible without a cloud vendor review or a new data-processing agreement.
The entire audit engine runs in the browser sandbox. Your .docx files are never sent to our servers, removing cloud DPA, egress risk and vendor access to unblinded trial data.
ClinOpsWord parses WordprocessingML locally to detect corrupted XML, orphaned numbering, stale cross-references and drifting styles — the issues enterprise research suites typically overlook.
Install on Windows, macOS or Chrome OS. No IT provisioning queue, no SSO scoping and no validation documentation sprint required to start auditing protocols and CSRs.
Built-in checks for data integrity, document structure and submission-readiness map directly to the guidance regulators cite in information requests and inspection observations.
Capability comparison
| Capability | ClinOpsWord | Typical Enterprise Clinical Suite |
|---|---|---|
| Document never leaves local device | Yes | No |
| Fixes Word XML/style corruption | Yes | No |
| Data-integrity cross-reference audit | Yes | Partial |
| No cloud DPA required to start | Yes | No |
| Trial/workflow management modules | No | Yes |
| SSO/SCIM provisioning | Enterprise | Yes |
| Validation documentation (IQ/OQ/PQ) | Enterprise | Yes |
| Deterministic, reproducible findings | Yes | Varies |
Built for
Need submission-ready protocols without waiting for IT to onboard another cloud vendor.
Need to repair .docx styles, numbering and cross-references before the CSR leaves the building.
Need a defensible, local-only audit trail that satisfies 21 CFR Part 11 and GDPR expectations.
Need to catch numeric drift between protocol sections and adverse-event tables before submission.
Related resources
A local-first alternative to enterprise RIM systems for document auditing.
Read the guideCatch numeric drift and broken cross-references inside the CSR before submission lock.
Read the guideHow a browser sandbox satisfies FDA electronic-records expectations without cloud risk.
Read the guideA practical checklist of modernized GCP requirements for trial documents.
Read the guideTry the full local-first audit engine. No credit card required. Institutional and Enterprise plans include the downloadable PWA desktop app and priority support.
Free users can explore the workspace. Software download unlocks with a trial or paid plan.
Common questions
Clinical research software covers the applications clinical operations, regulatory, data management and medical-writing teams use to plan, execute, document and submit clinical trials. ClinOpsWord is a specialized layer that audits Microsoft Word trial documents locally for data integrity and regulatory structure before they enter larger RIM, CTMS or eTMF workflows.
CTMS and eTMF platforms manage workflows, milestones and document repositories. ClinOpsWord audits the Word files themselves — protocols, CSRs and supporting documents — inside your browser, catching mechanical integrity issues that repository systems do not inspect.
No. It sits upstream of your CTMS, RIM, eTMF or eCTD publisher. It catches Word-level issues before documents are routed into the larger system, reducing rework and information requests.
ClinOpsWord is 21 CFR Part 11 aligned: documents stay on the local machine, audit trails are generated in the browser, and no remote server processes sensitive clinical data. Enterprise plans include validation documentation packs.
Yes. ClinOpsWord exports timestamped evidence reports as PDF, CSV or JSON that can be stored in your trial master file, quality system or document repository. The audit happens locally; the evidence feeds into your existing governance workflow.