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.