What it checks.
BryNaxa Study Data checks SDTM and ADaM datasets and their Define-XML metadata against CDISC conformance rules and controlled terminology, reporting findings by severity — the same class of checks a study clears before its data reaches the FDA.
It reads and writes the XPT and Dataset-JSON transport formats along the way, so you can work with the package in either representation.
Where it fits in the workflow.
Clinical and statistical programming teams preparing study data for submission. Run it before a delivery goes out, or when data arrives from a CRO, to see the conformance findings by severity before anyone downstream does.
Everything stays on your machine.
Runs fully offline on your own Windows computer. No account, no cloud, no telemetry — your files never leave the desk. Every result comes from a published method computed the same way every time, so the same input always produces the same findings. You keep the report as a plain file in your own systems.
Licensing is per organization, with team and site options. Contact [email protected] for licensing.
Coming soon.
BryNaxa Study Data is in preparation. To talk about access, licensing, or an evaluation for your team, get in touch and we’ll set you up.