CTIS User Personas for Zambon: the project is complete

Implementing the EMA User Personas Model for the Clinical Trial Information System (CTIS) project, which Maxer Consulting developed and implemented for Zambon, has been successfully completed.

The communication, training, and organisational alignment activities have supported the Zambon departments involved in clinical development in familiarising themselves with the CTIS platform processes throughout the entire life cycle of their clinical trials, from the Clinical Trial Application to the publication of results.

Through a series of interviews with the heads of the departments involved, the project focused on the management of clinical trials “AS IS” and identified the gaps with the requirements of the CTIS platform (“TO BE”).

A dedicated newsletter helped update the people involved in the project. At the same time, the training sessions committed to the “User Personas” model, the transition of clinical trials from the Clinical Trial Directive to the Clinical Trial Regulation, and the Transparency Rules increased the awareness of the new regulatory and operational scenario introduced by CTIS.

The work was formalised by updating the company’s Standard Operating Procedure for managing clinical studies and publishing the Working Instructions supporting compliance for clinical studies according to EU Regulation 536/2014.