From clinical data to submission-ready evidence—faster.
Automate the work between raw clinical trial data and regulatory analysis outputs without giving up control. Healytex combines AI-assisted data standardization, metadata-driven ADaM and TLF generation, continuous quality checks, and experienced biometrics specialists in one traceable workflow.
The last mile of clinical data is still too manual.
Clinical teams collect more data from more vendors than ever, but the path from database extracts to standardized datasets and analysis outputs still depends on fragmented specifications, repetitive programming, handoffs, and late-stage QC.
That creates avoidable rework exactly when timelines matter most.
| Domain | Status | Findings |
|---|---|---|
| DM | Complete | 0 |
| AE | In Review | 3 |
| LB | Complete | 0 |
One workflow from source data to analysis outputs.
Bring every source together
Bring EDC, laboratory, eCOA/ePRO, imaging, safety and specialty-vendor data into a governed study workspace with clear lineage.
AI-assisted mapping
Use AI-assisted mapping and reusable sponsor standards to move source data into CDISC SDTM with expert review and controlled execution.
Traceable analysis datasets
Turn approved SDTM and analysis specifications into traceable analysis datasets while preserving derivation logic and provenance.
Configuration-driven outputs
Create tables, listings and figures from controlled analysis metadata and reusable output templates—without rebuilding routine programming for every iteration.
Quality before the crunch
Run quality, conformance and sponsor-specific checks throughout the workflow so issues are surfaced before the submission crunch.
Biometrics extension team
Add experienced data managers, biostatisticians and statistical programmers as an extension of your team when you need hands-on execution.
Source to submission—every step traceable.
Describe the data path precisely: source/raw data → SDTM → ADaM → analysis results/TLFs → submission artifacts.
Source Data
EDC, labs, eCOA, imaging, vendors
Standardized
CDISC domains & metadata
Analysis-Ready
Derivations & populations
Analysis Outputs
Tables, listings, figures
Submission
Datasets, define, packages
Automation where it helps. Human judgment where it matters.
Connect your study data
Ingest structured and selected unstructured data from your clinical ecosystem.
Review intelligent mappings and specifications
The platform proposes standards mappings and transformation logic with confidence and context for expert review.
Generate standardized and analysis-ready outputs
Approved specifications drive repeatable SDTM and ADaM processing and configured analysis outputs.
Validate as you go
Automated rules, sponsor standards and QC workflows identify issues early and retain the evidence behind each resolution.
Package and deliver
Produce controlled datasets, metadata, documentation and analysis outputs for your regulatory submission workflow.
Built for evidence, not demos.
Clinical automation only matters when sponsors can trust the result. Healytex keeps the mapping, derivation, version, validation finding, resolution and approval history connected.
Your team can see how an output was produced, who approved it, and which rules were applied.
| Step | Source | Approved By |
|---|---|---|
| Mapping v2.1 | DM.SUBJID | J. Analyst |
| Derivation v1.4 | ADSL.TRT01P | S. Statistician |
| QC Check #847 | Population flag | Passed |
| Version lock | 2026-08-15 | DM Lead |
Sponsors building submission-ready evidence
Healytex gave us a single view of our data pipeline from vendor extracts through SDTM and ADaM. We caught mapping issues weeks earlier than our previous process.
The traceability story was what sold us. Every derivation, every approval, every QC finding—connected. That's what regulators and our internal QA team need to see.