EMA Clinical Trials Information System (CTIS) CRO / Sponsor Organization Models in CTIS

As of January 31st, 2022 all research on human subjects with medicinal products in the EU need to be submitted via the EMA Clinical Trial Information System, the CTIS. In the current transition period, organizations focus on the setup of the optimal organisation model in CTIS, which ensures a smooth collaboration between CROs and Sponsors and enables optimal use of the standardized timelines of EU CTR.