Accurate data. Complete audit trails. Controls that span every pipeline.
In regulated clinical work, data must be right—not approximately right. Healytex is built so every transformation is verifiable, every decision is logged, and quality, conformance and security run horizontally across SDTM, ADaM and TLF—not as afterthoughts at the end.
Accuracy is the requirement—not a nice-to-have.
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
- Findings tracked, resolved and evidenced before outputs are accepted
- 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.
Audit trails are not a reporting feature—they are how sponsors, CROs and regulators reconstruct what was done, when, by whom and on what authority. Every material action in Healytex is captured with user identity, timestamp, object version and context.
- Immutable logs for approvals, executions, locks and releases
- Version-linked evidence—outputs tied to exact spec and code versions
- Role-based access with every login and permission change recorded
- Inspection-ready history without reconstructing email threads
Quality, conformance and security—across every pipeline.
These are not separate deliverables bolted on at the end. 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 built into every run
Reconciliation, validation rules, independent QC and explicit approval gates ensure outputs are correct before they move downstream—not discovered in a final review cycle.
Standards-aligned by design
CDISC SDTM and ADaM conformance, Define-XML alignment, controlled terminology and sponsor-specific rules are checked continuously—not patched after the fact.
Protected 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 throughout.
AI assists, experts approve
AI-assisted features make recommendations; qualified users remain accountable for study-specific decisions. Approval gates are explicit, logged and tied to the exact output version in the audit trail.
Risk-based computer system validation
We apply a risk-based CSV approach to the intended use of the platform—controlled requirements, testing, release documentation, change control, access management and operating procedures.