Follow us on  LinkedFit for Health LinkedIN

Is subcontracting allowed for clinical validation in PHC 12?

Question details: 
Currently we are interested in the Health topic of the SME Instrument. The question we have is that according to the Proposal Template for Phase 2 the core activities of the project cannot be subcontracted. As in PHC12 the core activity is the clinical validation of biomarkers and/or diagnostic devices, does this means that we cannot subcontract the services of a CRO and/or a hospital? Will we have to hire our own doctors and recruit patients? We don't have the intention of becoming a CRO, we just want to commercially exploit our devices.

As opposed to other instruments, the SME instrument (Phase 2) does not have any restrictions when it comes to subcontracting of tasks; see article 13 (p. 370):

The rules on subcontracting for SME Instrument Ph2 actions are similar to those of the General MGA (see Article 13 General MGA).
However, subcontracting is not restricted to a limited part of the action.

This means that the participating SMEs can subcontract the services of a CRO and/or a hospital without a problem.