CTIS: Tailored training for Erydel
On November 21, Erika Ornago and Massimo Zaninelli created the training program dedicated to the EMA Clinical Trials Information System (CTIS) and the User Personas model for the Clinical Operation Team of Erydel S.p.A.
The first part of the course summarized some concepts and processes of CTIS, while the second part focused on the definition of the organizational model required by the new portal. CTIS involves a significant change in the management of the life cycle of clinical studies and can require a large amount of work in a short time, which is particularly burdensome for sponsors.
The obligation to use CTIS – and no longer EudraCT – will take effect from January 31 2023, requiring the registration of all new clinical studies in CTIS and the transition of those registered on EudraCT and not yet completed. It is now urgent for sponsors to acquire the necessary skills on Regulation 536/2014 and the use of the CTIS. It is also critical to verify whether the organizational models adopted to date meet the requirements of the new EMA portal.
The User Personas model, developed by EMA and integrated by Maxer according to the change management approach, makes it possible to align the organizational model of the sponsors with the CTIS requirements by identifying responsibilities and promoting collaboration between internal and external subjects of the sponsors and those involved in the cycle of clinical trials.
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.