FDA · EMA · ICH E6 (R3)

One number that disagrees with your database can cost you a review cycle.

ClinOpsWord audits Word protocols and CSRs for numeric discrepancies, Word/XML corruption and ICH E6 structural gaps — audited entirely in your browser, so nothing ever leaves your machine.

No document upload Runs on any modern browser Deterministic, reproducible output
Data IntegrityStyle / XMLICH E6 (R3)
Illustrative render of the audit pass: numeric tokens resolving to pass or conflict across a document stack.

Zero document bytes transmitted — verifiable in your browser's Network tab

Deterministic engine: identical input always yields identical findings

Ineligible documents are rejected, not scored — no invented findings

Don't take our word for it

Run a real audit right here, before you sign up.

This is the production audit engine, running in this page. Drop a .docx and it is unzipped and parsed in your tab. If you would rather not use a live document yet, run the bundled sample protocol — its findings are computed from the sample text by the same engine, not hardcoded.

Open DevTools → Network, then run the analysis. No request carries your document.

In-browser sandbox

0 bytes uploaded

Drop a protocol or CSR (.docx) here — it stays on this machine.

What this prevents

Information requests are usually caused by arithmetic, not science.

A discrepancy that reaches a regulator returns as a request for information: a response cycle, a document re-issue, a re-review. The three failure modes below are the ones a machine can catch reliably and a tired reviewer cannot.

Data Integrity

Numbers that disagree with each other

A subject count in the narrative that does not match the disposition table, an alpha level that drifts from the SAP, an adverse-event total that no longer reconciles after a data cut. Each one is a plausible information request, and each request costs review cycles.

Word / XML

Structure that silently corrupts

Orphaned numbering references that black out bullet numbers, a table of contents frozen at an earlier revision, non-standard fonts inherited from a partner's template. These survive PDF rendering and reach the submission packet.

Scale

Manual QC does not scale to a CSR

Cross-checking dozens of numeric fields across several hundred pages by hand, under a lock deadline, across timezones. Reviewers are good at judgement and bad at exhaustive arithmetic — the failure mode is systematic, not careless.

Illustrative, not a case study: ClinOpsWord is new and we publish no customer outcomes or savings figures we cannot evidence.

Product walkthrough

Upload, analyse, drill down, export.

The workspace shows every processing stage as it completes, including a live counter of network requests made during analysis. The steps below are the real flow — you can walk it yourself in the sandbox above.

  1. 1

    Drop your protocol or CSR

    Optionally add a trial database export (ADSL/ADAE CSV) for cross-referencing. Files are read from disk, not uploaded.

  2. 2

    Local, in-browser analysis

    The tab unzips the .docx, parses WordprocessingML, extracts every numeric token, and runs the enabled checks. You can watch each stage complete.

  3. 3

    Review flagged discrepancies

    Each finding carries the verbatim excerpt, its section location, a risk tier, and the regulatory reference it maps to. Drill down to the exact block.

  4. 4

    Repair and export

    Apply in-memory style/XML repairs, then export the audit report as PDF, CSV or JSON for your submission packet.

Three modules

What the engine actually checks.

Data Integrity

Declared subject counts, alpha levels and safety totals that disagree between narrative sections, or with a trial database export you supply.

Example finding: “Section 4.2 declares N=300; the disposition table totals 298” — with the excerpt and section shown.

Numeric inconsistency is the most common avoidable trigger for a regulatory information request.

If you supply no database export, cross-referencing is reported as skipped — never guessed.

Style Repair

Orphaned numbering IDs, missing or stale tables of contents, and non-standard fonts inside the Word package.

Example finding: “12 orphaned numId references in word/numbering.xml” — counted from the actual file.

Structural defects render inconsistently at the agency's end and undermine document control.

Repairs are applied to an in-memory copy; your original file on disk is untouched until you export.

ICH E6 Audit

Missing or unlabelled sections required by ICH E6 (R3) protocol structure, and absent safety-reporting language.

Example finding: “No section addressing adverse event reporting timelines was located.”

Structural gaps are caught by reviewers before science is even discussed.

Presence checks are text-based; they flag what to inspect, they do not certify compliance.

Local Sandbox Mode: Active (Data Secured Locally)

How local processing actually works.

A .docx is a ZIP archive of XML parts. When you choose a file, the browser hands the page its bytes; ClinOpsWord unzips that archive in memory, reads word/document.xml along with the styles and numbering parts, tokenises the narrative, and runs the checks — all inside the page. There is no upload step because there is no server-side analysis component to upload to.

You can confirm this rather than trust it: open your browser's developer tools, switch to the Network tab, and run an analysis. The workspace also shows a live request counter during processing, read from the browser's own performance timeline.

HIPAA
Unblinded or identifiable data is never disclosed to us because it never leaves the device — there is no processor to sign a BAA with for document content.
GDPR
No personal data is transferred or stored by the analysis, so no cross-border transfer mechanism is engaged for the document itself.
21 CFR Part 11
Audit output is a deterministic, reproducible record you retain and control, generated from the exact file you supplied.

No server transfer

Documents are read from disk into memory and discarded when the tab closes.

In-browser parsing

Unzip, WordprocessingML parsing and tokenisation all execute in the page.

Installable runtime

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

Evidence you keep

Reports export locally as PDF, CSV or JSON; we never hold a copy.

Early access — no testimonials yet

We would rather show the method than borrow credibility.

ClinOpsWord is new. There are no customer logos, testimonials or user counts on this page because there are none we can evidence — and this audience checks. Here is what we can put behind the product instead.

Why it was built

It comes out of working inside clinical document workflows — the QC pass where a reviewer reconciles narrative numbers against tables and database exports by hand, days before a lock. That task is mechanical, exhausting and exactly the kind a deterministic tool should own.

Try it yourself as the proof

Because analysis is local, evaluation costs you nothing and exposes nothing. Run your own protocol through the sandbox above and judge the findings against what you already know is in the document.

Methodology in the open

Every finding states the check that produced it, the verbatim excerpt, the section, a risk tier and the regulatory reference. The Health Index is a weighted pass rate over the checks that actually ran — skipped checks never count as passes.

Plans

Evaluate on your own, buy when it earns it.

Clinical Trial

$99/month

  • Single practitioner workspace
  • All three audit modules
  • PDF / CSV / JSON audit exports
  • 7-day free trial — card verified, not charged
See full plan details

Institutional

$499/month

  • Team access and PWA installation
  • Configurable audit rule sets
  • Database cross-reference workflows
  • Priority support
See full plan details

Enterprise Sovereign

Contact sales

  • IQ/OQ validation documentation
  • 21 CFR Part 11 control mapping
  • SSO and invite-only access codes
  • SDTM / ADaM connector scoping
See full plan details

You won't be charged today. Your 7-day free trial starts after your payment method is verified, and you will be charged the selected plan price after the trial ends unless you cancel before it expires.

FAQ

The questions you should ask.

Early access

Test it on a real document — then tell us what it missed.

Founding users shape the check library and the validation pack. Run your own protocol first; if the findings are useful, join the early access cohort and we will prioritise the checks your programme needs.

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