IVD Performance Studies
- Clinical Performance Study design and protocol development including statistical sample size calculations/justification.
- Conduct of IVD performance studies in compliance with ISO 20916 and IVDR requirements.
- Existing collaboration with sites and pre-qualified laboratories.
- EC/IRB and Regulatory submissions/notifications.
- Fee negotiation and clinical trial agreements.
- Setup of EDC system and ongoing data management services.
- Monitoring and ongoing safety reporting.
- Statistical analysis and report.
- Clinical Performance Report writing.