Five applications, one platform

Each application is useful on its own. Together they cover the work from a legacy migration through development and validation to a filed submission.

Norva Studio

A GxP ready workspace for developing regulated statistical analyses, with the environment, packages and audit trail qualified before anyone writes code.

21 CFR Part 11Validated RGit

Norva Bridge

Moves a SAS estate onto validated open analytics, with equivalence testing that shows the new output matches the old one before anything is retired.

SASEquivalenceMigration

Norva Review

Measures submission readiness continuously rather than at the end, across SDTM, ADaM, define.xml, controlled terminology and traceability.

SDTMADaMdefine.xml

Norva Copilot

Domain aware assistance for programming, quality control and review, where every answer is grounded in your standards and every action is recorded.

AgentsPrivate LLMAudit trail

Norva Publish

Turns validated analyses into tables, listings, figures, narratives and clinical study reports, under version control and electronic approval.

TLFCSRNarratives

What sits underneath

Every application runs on the same services, so identity, audit, validation and compute are solved once rather than five times.

Identity, security and access control

  • Single sign on, multi factor authentication, role based access, organisation and study management.

AI, knowledge graph and audit

  • Enterprise retrieval, a model registry, prompt governance and an immutable record of what the system did.

Workflow, validation and APIs

  • Review and approval routes, the validation lifecycle, SOP enforcement, change management and REST access.

Compute, storage and version control

  • Elastic and distributed compute, GPU execution, object storage, clinical data connectivity and Git.

Shared platform services

Compute

  • Elastic compute
  • Distributed R
  • GPU execution
  • Containerised workloads
  • Scheduled jobs

Data

  • Data lake connectivity
  • Clinical databases
  • Object storage
  • Secure file management
  • Metadata catalog

Governance

  • Role based access control
  • Single sign on
  • Multi factor authentication
  • Organisation management
  • Study management

Compliance

  • Immutable audit trails
  • Electronic signatures
  • Validation lifecycle
  • SOP enforcement
  • Change management

AI platform

  • Enterprise retrieval
  • Knowledge graph
  • Model registry
  • Prompt management
  • AI governance

Integrations

  • SAS
  • R
  • Python
  • GitHub and GitLab
  • CDISC
  • Pinnacle 21
  • Clinical data repositories
  • REST APIs

How the applications fit together

Studio

  • Where regulated analytics are developed

Bridge

  • Brings a legacy SAS estate onto the platform

Review

  • Measures submission quality continuously

Copilot

  • Accelerates programming, QC and review

Publish

  • Turns validated analyses into deliverables

Want to see how Norva would fit your studies?

We will walk through your current stack, where the validation effort goes, and which part of the platform earns its place first.