Sponsors can sign up to participate in the COMBINE pilot
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 Project 1 – pilot “all-in-one” coordinated assessment - European Commission