Norva Review
Know you are submission ready.
Continuous measurement of submission readiness across SDTM, ADaM, define.xml, controlled terminology and traceability, rather than a scramble at the end.
What it is for
Readiness is usually discovered late, when the cost of fixing it is highest. Review scores it while the work is still in progress.
Validation
- SDTM validation
- ADaM validation
- Metadata validation
- Controlled terminology validation
- Pinnacle 21 integration
Define and traceability
- Define.xml generation
- Define.xml validation
- Traceability analysis
- Version comparison
Oversight
- Submission readiness score
- Risk dashboard
- Compliance dashboard
- Submission checklist
- Reviewer workflows
- Approval workflows
Assistance
- Explain validation issues
- Suggest fixes
- Risk prioritisation
- Readiness forecasting
- Submission insights
What you receive
- Submission package
- Readiness report
- Compliance report
- Audit package
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.