Delivered a full CTR transition in 7 days with no regulator queries
Urgent CTR Transition - A Rapid Solution for Study Continuation
Context
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.
Lumis' solution
Lumis’ solution was based on the following three pillars:
- Strategy: Lumis devised a strategy to submit the minimal transition dossier, in accordance with the European Commission’s guidance.
- Project Management: Using project management tools and checklists, Lumis outlined a targeted timeline and document list for a successful submission.
- Prioritisation & Communication: Given the timeline sensitivity, this project was prioritised by Lumis’ senior regulatory expert, who maintained regular contact with the client. During the submission, Lumis’ regulatory expert raised the timeline and study continuation risk with the authorities to ensure it was processed in a timely manner.
Result
Why this matters to sponsors
Trial submissions close to regulatory deadlines risk not only the trial but the entire development timeline. To address these high-pressure scenarios, the simplest package must be prepared with prioritisation and transparent communication with the regulators. This provides a pragmatic framework for sponsors to follow if under such pressures.
