CCMO is looking for sponsors to participate in the pilot all-in-one procedure of the European COMBINE program. This program aims to address bottlenecks in combined studies for both sponsors and assessors.

During the pilot it is possible to submit a single application for a combined study in CTIS. Currently, this is only possible for studies with companion diagnostics (CTR/IVDR).

Sponsors can now sign up to participate in the pilot. It is not possible to register via CCMO. Applications can be submitted through the European Commission website: combine programme – European Commission