Dompé entrusts Maxer with the CTD and CTIS 2022 projects

We are pleased to announce that Dompé S.p.A. has entrusted Maxer Consulting with implementing the Clinical Trial Disclosure (CTD) programme and consulting to implement the EMA Clinical Trial Information System (CTIS) in its organization for 2022.

CTD’s activities require Maxer to ensure compliance by Dompé with the regulations in force in the European Union (EU Reg. 536/2014) and in the United States (FDAAA 801 and Final Rule), making public Dompé’s clinical trial results according to foreseen norms.

As for the implementation of CTIS, Maxer will implement a targeted change management program to align the Dompè organization with the requirements of the new EMA platform for the management of the life cycle of clinical trials in EU / EEA countries.