Zambon creates the EMA User Personas for CTIS project
With the kickoff meeting on March 4th, Zambon S.p.A. started the implementation of the “EMA User Personas Model for the CTIS” project, the organization of which is entrusted to Maxer Consulting.
The project, with its focus on communication, training, and organizational alignment activities, is designed to prepare Zambon to manage the requirements of the CTIS platform during the entire life cycle of its clinical studies, from the Clinical Trial Application to the publication of the results.
The project group involves the departments that play operational and support roles in implementing clinical studies. Their representatives will participate in update meetings, training sessions on the evolution of CTIS and interviews with Maxer consultants.
Once the “AS IS” model has been defined, Maxer will compare it with the organizational requirements of CTIS and will propose to Zambon any amendments to the clinical trial management procedures, including those of delegation and monitoring. Once discussed and validated, these amendments (the “TO BE” model) can be integrated into the company’s operating procedures, ensuring compliance with the studies within the EU Regulation 536/2014 framework.
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