Norva Studio
A GxP ready workspace for developing regulated statistical analyses, with the environment, packages and audit trail qualified before anyone writes code.
Clinical, pharmaceutical, biotech and diagnostics teams develop, validate, review and submit scientific analyses in one place, with compliance, governance and AI built into the platform rather than added around it.
Each application is useful on its own. Together they cover the work from a legacy migration through development and validation to a filed submission.
A GxP ready workspace for developing regulated statistical analyses, with the environment, packages and audit trail qualified before anyone writes code.
Moves a SAS estate onto validated open analytics, with equivalence testing that shows the new output matches the old one before anything is retired.
Measures submission readiness continuously rather than at the end, across SDTM, ADaM, define.xml, controlled terminology and traceability.
Domain aware assistance for programming, quality control and review, where every answer is grounded in your standards and every action is recorded.
Turns validated analyses into tables, listings, figures, narratives and clinical study reports, under version control and electronic approval.
Every application runs on the same services, so identity, audit, validation and compute are solved once rather than five times.
We will walk through your current stack, where the validation effort goes, and which part of the platform earns its place first.