The Norva platform

The software our teams use on regulatory and clinical programmes, available to Indian sponsors and CROs running their own. Same platform as our global practice, with the Indian filing route treated as a first class case rather than an afterthought.

Built for sponsors who file in more than one place

An Indian sponsor rarely files once. The same programme goes to CDSCO through SUGAM, registers on CTRI, and often goes to the FDA or EMA as well, with the same datasets expected to satisfy reviewers who ask different questions of them. Work that is reproducible for one is usually reproducible for the others; work that is not fails twice.

Norva is five applications on one platform. Each is useful on its own, and together they cover a programme from a legacy migration through development and validation to a filed dossier.

Norva Studio

A qualified environment for statistical programming, so the question of which R version and which packages produced a result is answered by the workspace rather than reconstructed later.

Norva Bridge

Moves a SAS estate onto validated open analytics, with equivalence testing that shows the replacement produces the same numbers before anything is switched off.

Norva Review

Checks submission readiness continuously against CDSCO expectations and CDISC standards, for sponsors filing in India and abroad from the same study.

Norva Copilot

Assistance for clinical programming and quality control that knows the data standards, and records what it did so a reviewer can follow it.

Norva Publish

Tables, listings, figures and clinical study reports produced from validated analyses, under version control and electronic approval.

What sits underneath

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

The audit trail is immutable and the validation lifecycle is part of the platform rather than a document set maintained beside it. That matters most at inspection, when the question is not whether the analysis was right but whether you can show how it was produced.

Identity and accessSingle sign on, role based access, study and organisation management
Audit and signaturesImmutable trails and electronic signatures across every application
Validation lifecycleQualification evidence, SOP enforcement and change management
Compute and storageElastic and distributed compute, object storage, clinical data connectivity
Version controlGit for code, specifications and outputs alike
IntegrationsSAS, R, Python, CDISC, Pinnacle 21, GitHub and GitLab, REST APIs

Want to see it against one of your own studies?

We will take a study you are running now and show what the platform does with it, including where your current process would have to change.

Talk to our team See our regulatory services