Business priorities and compliance needs must harmonize in applying the rules on the transparency of clinical trials.

Maxer informs its client sponsors of the disclosure priorities and proposes, where required, a priority plan aimed at minimizing the consequences of non-compliance, such as regulatory issues, monetary penalties, and risk of prosecution.

Clinical trial registration in the Clinical Trial Information System requires constant updating in knowledge of the procedures defined by the EMA and in the management of the study lifecycle. Maxer continuously trains its consultants to support clients through the transition phase until the release of CTIS, which will coincide with the full implementation of Regulation 536/2014.