CTD/DT 2023-24 & CTIS Working Instruction for Dompé
We are pleased to announce that Dompé S.p.A. has entrusted Maxer Consulting with implementing the Clinical Trial Disclosure and Data Transparency (CTD/DT) program for 2023-24.
CTD’s activities require Maxer to ensure compliance by Dompé with the regulations in force in the European Union (EU Reg. 536/2014) and the United States (FDA Amendment Act 801 and Final Rule), making public Dompé’s clinical trial results according to foreseen norms.
As for the implementation of the EMA Clinical Trial Information System (CTIS), Maxer will perform a targeted training program to help align the Dompè organization with the requirements of the new EMA platform. Furthermore, Maxer will draw up the Working Instructions that Dompé will adopt for managing the life cycle of clinical studies through CTIS.