Clinical Trial Regulation
The Clinical Trial Regulation (CTR) is the new EU regulation that replaced the current Clinical Trial Directive (CTD). It went live on 31 January 2022 and became mandatory for all new trials from 31st January 2023, with any ongoing trials needing to be transitioned by January 2025.
Basic or Full CTIS - CTR training
We can train all levels of your organisation on new ways of working under the CTR.
Dossier Preparation
With changes in requirements and increased focus on transparency, we can help with all aspects of dossier preparation under the Clinical Trial Regulation (CTR) from review of templates and content to a full authoring service.
Tailored CTR Services
Evaluation of clinical trial workflow and procedures to adapt to new CTIS functionality and day-to-day use. Identification of strategies and planning for the transition period of existing and/or new trials. Identifying local requirement needs in addition to centralise CTIS functions.
SOP Updates
We can assist in all aspects of SOP updates as a result of the Clinical Trial Regulation (CTR) to be compliant with the new process and to implement SMR recommendations.
