FAQ
Frequently asked questions
Common questions about the Healytex platform, our services and how we support regulated clinical data workflows.
No. The platform is designed to reduce repetitive manual programming and support multiple execution approaches while preserving the specifications, transformations and evidence needed for regulated work. Sponsors can retain SAS where required and introduce other validated technologies where appropriate.
No. AI-assisted features can propose mappings and specifications, but regulated study decisions should be reviewed and approved by qualified users. Approved specifications drive controlled, reproducible processing.
Yes. The operating model is designed to ingest data from multiple systems and vendors and can be used by a sponsor, alongside a CRO, or as a technology-enabled biometrics service.
The platform is designed around CDISC study-data and analysis standards and supports version-controlled sponsor standards and controlled terminology. Specific supported versions are listed in the product documentation and statement of work.
Routine outputs can be generated from controlled analysis metadata and reusable templates. Complex or novel analyses may still require statistical/programming expertise, and all outputs remain subject to the sponsor's review and QC requirements.
Selected documents and unstructured sources can be indexed or analyzed for operational and data-review use cases. Any use that affects regulated analysis or study conclusions is governed by the same intended-use, validation, lineage and review principles as structured data.
A focused readiness assessment or single-study pilot is the fastest starting point. Final timing depends on study complexity, data quality, vendor inputs, standards and the required deliverables.
No responsible vendor can guarantee an agency outcome. We design and deliver work to applicable study-data standards and sponsor requirements, maintain traceability and validation evidence, and support the sponsor's submission-readiness process.