Norva Review
Submission readiness measured continuously against CDISC standards and the expectations of the authority you are filing with, rather than discovered in the week before the dossier goes out.
One study, more than one reviewer
A sponsor filing in India and abroad prepares one set of datasets for reviewers who ask different questions of them. CDSCO reads a dossier submitted through SUGAM; the FDA reads define.xml and traceability. The underlying work is the same, and so are the ways it goes wrong.
Review scores readiness while the work is still in progress, which is the only point at which fixing it is cheap.
- SDTM and ADaM validationAgainst current CDISC versions
- Define.xmlGenerated and validated, not written afterwards
- Controlled terminologyChecked against the version you declared
- Traceability analysisFrom a value in a table back to its source
- Pinnacle 21 integrationAlongside the platform's own checks
- Version comparisonWhat changed between runs, and why
Oversight a programme manager can use
A readiness score is only useful if it points at work. Issues are ranked by what would actually stop a reviewer, and routed to the person who can fix them.
- Readiness scorePer study, tracked over time
- Risk dashboardWhat would stop a filing, ordered
- Reviewer workflowsAssignment, comment and approval
- Submission checklistAgainst the route you are filing
- Audit packageThe evidence trail, assembled
- Compliance reportingFor quality and for the sponsor
Want a readiness score on a study you are running now?
We will run your current datasets through the checks and show you where a reviewer would stop.