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.
The Clinical Trial Information System‘s future release will require a significant upgrade in Clinical Trial Application and study lifecycle management. Maxer continuously trains its consultants to accompany clients in the transition phase until the release of CTIS which will coincide with the complete application of Regulation 536/2014.