Clinical Study Plan

Purpose and goal:

The main purpose of the project was to enable an accelerated clinical evaluation of JUNO-Checked through international collaborations and knowledge transfer, which in addition will contribute to obtaining CE certification in the EU, as well as other regulatory approval and a global market positioning. The main goal is to enable comprehensive demonstration of our technology in the clinical environment to Venture Capitalists and secure EIC accelerator funding which will bridge the gap between the current stage of development, and the readiness of JUNO-Checked for market launch.

Expected results and effects:

The establishment of the regulatory plan and the eQMS shall maximise oversight of quality processes throughout the product life-cycle with a well designed workflow built-in system that aligns with medical device regulations, including In Vitro Diagnostics Regulations.

The study plan shall further facilitate acceleration of the clinical performance study which will enable us to extensively demonstrate our technology in the clinical settings and get ready for market entry in 2022. Approach and implementation: Regulatory Plan

In Place: Regulatory plan, Establishment & Implementation of eQMS; Staff training based on the QMS in accordance with the regulations for the ISO13485. Ongoing: None Study Site Selection

In Place: Identification and Verification of the adequacy of the Clinical Investigation site (IVF clinic);Verification of qualifications of principal investigator; Setting up agreements for the selected study site Ongoing: None Study Design In Place: Establish & outline study objectives; study procedures and monitoring plan

Ongoing: Study submissions to the Ethical Committee