A secure, local-first QC tool for Clinical Study Reports. Catch numeric drift, broken cross-references and structural gaps inside the CSR before submission — no document upload, no cloud vendor review.
Why manual CSR QC is hard to scale
A safety total in the summary narrative differs from the adverse-event table on page 312. Manual cross-checking hundreds of pages against statistical output is slow, and a single mismatch can trigger an agency information request.
Tables, listings and figures are referenced by numbered bookmarks that can break during global template updates. A broken or stale cross-reference reaches the reviewer as an apparent inconsistency even when the data is correct.
When tables are pasted from spreadsheets, the link to the source dataset is lost. Subsequent data cuts may update the listing but leave the CSR narrative or summary table pointing at an older value.
ClinOpsWord installs as a Progressive Web App and runs every audit locally: tokenization, .docx unzipping, WordprocessingML parsing and numeric cross-reference analysis happen inside your browser. That makes total HIPAA and GDPR alignment possible without a cloud vendor review or data-processing agreement.
The CSR, the database export and every extracted numeric token stay inside the browser sandbox. That removes the cloud DPA, vendor security review and data-residency risk that delay most outsourced QC tools.
ClinOpsWord extracts every number in the narrative and compares it against declared totals, protocol values and an optional ADSL/ADAE CSV. If no database is supplied, the check is reported as skipped — never fabricated.
Install as a PWA and audit the CSR chapter by chapter. Repair orphaned numbering, stale cross-references and corrupted XML in memory, then export the evidence report for your submission file.
Findings map to data integrity, structure and submission-readiness expectations cited by regulators in information requests and inspection observations.
Capability comparison
| Capability | ClinOpsWord | Manual Review |
|---|---|---|
| CSR contents stay on local machine | Yes | No |
| Automated numeric cross-check vs. database | Yes | Partial |
| Detects broken cross-references | Yes | Partial |
| Rejects ineligible or non-clinical documents | Yes | No |
| Timestamped audit trail per reviewer | Yes | No |
| Scales to 500+ page CSRs without fatigue | Yes | No |
| Deterministic score and findings | Yes | No |
Built for
Need to verify that CSR narrative, tables and listings are internally consistent before the final edit pass.
Need a fast, deterministic way to confirm that reported totals agree with the analysis datasets.
Need a defensible local-only audit trail that supports 21 CFR Part 11 and inspection-readiness expectations.
Need to catch data-cut drift between database exports and the CSR before submission lock.
Try the full local-first CSR 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 study report auditing is the quality-control pass that checks a CSR for internal consistency, numeric accuracy against source datasets, correct cross-references and regulatory structure before submission. ClinOpsWord automates this mechanically and deterministically inside the browser.
The CSR and any ADSL/ADAE CSV are read into the browser tab, parsed in memory, and never uploaded. There is no cloud processing step, so there is no vendor access to unblinded patient data and no cross-border transfer to manage.
No. It handles the mechanical consistency checks — same input always produces the same findings — so human reviewers can focus on scientific interpretation, medical context and regulatory messaging.
Yes. When no CSV is supplied, the database cross-reference checks are reported as skipped and do not count toward the Health Index. Internal consistency checks such as style, numbering and cross-reference integrity still run.
Yes. Every check, result and repair is timestamped and bound to the authenticated user. Reports export locally as PDF, CSV or JSON for storage under your own quality system.
Related resources: Regulatory submission software · 21 CFR Part 11 compliance software
Enterprise sovereign deployment
Our team helps global pharma deploy ClinOpsWord alongside existing RIM, biostatistics and eCTD workflows. Ask for air-gapped options, SSO/SCIM provisioning, validation documentation and regulated-industry support SLAs.