Only limited part of the action can be subcontracted (Art. 13 MGA).
For subcontracting to CROs: If the clinical study is the main activity of the project, core study expertise cannot be subcontracted. However, certain parts (e.g. GMP manufacturing) might be subcontracted as long as general regulatory expertise is available and the study design, high-level study management and oversight remain as tasks within the consortium.
If the clinical study is just a small part of the project, i.e. most of the project is preclinical activity, the study might be subcontracted in its entirety.