A Swedish investigator-led study contacted Lumis for support in transitioning to the Clinical Trials Regulation (EU) 536/2014 – the project kicked-off on 17 October 2024. The deadline for transition was the 31 January 2025. However, transition applications could take up to 106 days meaning there was a real risk the study could not be transitioned in time and would have to stop all activities to avoid non-compliance.

An American biotechnology firm developing a therapy for phase II study in kidney disease needed support with their clinical trial application in the EU’s Clinical Trial Information System (CTIS).