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).

A company from Asia needed support with the EMA Scientific Advice for their drug-device combination product. The client prepared a draft briefing document for the advice meeting, however, due to their unfamiliarity with the EU process and the complexities of the drug-device product, they needed specialised technical input. Support for the science advice focused on Chemistry, Manufacturing, and Controls (CMC) and clinical development but also had questions on preclinical development and implications for the product’s classification. Hence, to manage this project required a multidisciplinary team.

A biotechnology firm developing an immunotherapy for small-cell lung cancer contacted Lumis for support with an EMA orphan designation application. The client was a small, innovative company with very limited resources.