Phase 2 suppliers will develop their solution and demonstrate their analytical validity having followed the Analytical test plan approved in Phase 1. The Analytical validation will consist of demonstration of assay performance (accuracy, precision, specificity, etc.). During Phase 2, suppliers will be requested to deliver the clinical validation protocol of the pre-commercial devices and Data Management Plan (‘DMP’) (including patients’ consents) they will perform in Phase 3.
At the end of the Phase 2, the invitation to Phase 3 (call-off) will be issued.
Overall duration: 15 months
Execution : 12 months