Training on the CTIS User Personas model for Italfarmaco S.p.A.
The two four-hour sessions each focused on defining the organizational model to support the EMA Clinical Trials Information System. CTIS involves a significant change in the management of the life cycle of clinical trials and, in some conditions, imposes a high amount of work on sponsors in a short time.
The now imminent second phase of the transition from the Clinical Trial Directive of 2001 to the Clinical Trial Regulation of 2014, scheduled for January 31, 2023, will require registering all new clinical studies in CTIS and transitioning those registered on EudraCT and not yet completed. The need to register clinical trials under CTIS makes it urgent for sponsors to check whether their current organizational model adequately meets the requirements of the new EMA portal.
The User Personas model, developed by EMA and integrated by Maxer according to the change management approach, proposes a method to align the sponsors’ organizational model with the CTIS requirements by identifying responsibilities and promoting collaboration between the departments involved in the clinical trial cycle.
Maxer designs and implements training and consultancy activities to support sponsors in the delicate transition phase towards the application of CTR 536/2014 through the CTIS portal.