A new “Article 11 workaround” is addressing a long-standing limitation in CTIS when working with Part I-only submissions in multi-country clinical trials.
Sponsors can now include Member States with only Part I in the initial submission by using placeholders for Part II—making it easier to:
• Add new Member States
• Submit substantial modifications
• Avoid process bottlenecks
A practical step forward in making CTIS workflows more adaptable to real-world study needs. Read more about this workaround in this CTCG guidance from the Clinical Trials Coordination Group (CTCG).
At Aurevia, we’re seeing how small system changes like this can have a meaningful impact on planning and execution across multi-country trials.
Do you need support with your CTIS submissions? Our clinical trial experts can support your regulatory submissions during your entire clinical study, from start-up to close-out.
Our clinical experience, flexibility, and strong local presence enable us to deliver support that keeps studies moving forward. Contact us to learn more or if you need support with an upcoming clinical study.
