Accurate data, complete audit trails, and controls that run across every pipeline.
In regulated clinical work, data has to be exactly right. We built Healytex so you can verify every transformation, so every decision leaves a log entry, and so quality, conformance and security run across SDTM, ADaM and TLF from intake onward.
Accuracy is the requirement.
Clinical submission data has no margin for silent errors. A wrong mapping, a missed derivation or an unexplained value difference can invalidate weeks of work. Healytex treats accuracy as the primary outcome of every pipeline run.
- Source-to-target reconciliation at variable and record level
- Independent QC and validation against approved specifications
- Controlled execution: approved specs drive deterministic processing
- We track, resolve and document every finding before accepting an output
- Human review gates for study-specific and edge-case decisions
| Check | Result | Evidence |
|---|---|---|
| Source reconciliation | Pass | Log #2841 |
| Variable derivation | Pass | Spec v2.1 |
| Controlled terminology | Pass | CT v2024-03 |
| Cross-domain consistency | Review | Finding #12 |
If it isn't logged, it didn't happen.
Sponsors, CROs and regulators use audit trails to reconstruct what happened, when, who did it and on what authority. Healytex captures every material action with user identity, timestamp, object version and context.
- Immutable logs for approvals, executions, locks and releases
- Version-linked evidence: each output names the exact spec and code version behind it
- Role-based access, with a record of every login and permission change
- Inspection-ready history without reconstructing email threads
Quality, conformance and security across every pipeline.
Quality, conformance and security are horizontal services that run through SDTM Automation AI, ADaM AI and TLF Studio AI from intake to submission-ready output.
Accuracy checks in every run
Reconciliation, validation rules, independent QC and explicit approval gates confirm that outputs are correct before they move downstream, so errors do not surface in a final review cycle.
Standards alignment, checked continuously
We check CDISC SDTM and ADaM conformance, Define-XML alignment, controlled terminology and sponsor-specific rules continuously, rather than patching them afterwards.
Protection at every layer
Encryption in transit and at rest, least-privilege access, secure development practices, vendor oversight and documented incident-response procedures protect clinical data at every stage.
AI assists, experts approve
AI-assisted features make recommendations. Qualified users remain accountable for study-specific decisions. Every approval gate is explicit, and the audit trail links it to the exact output version.
Risk-based computer system validation
We apply a risk-based CSV approach to the platform's intended use: controlled requirements, testing, release documentation, change control, access management and operating procedures.