The anonymization and redaction of clinical studies for each registration dossier are established under EMA Policy 0070/2014. Maxer oversaw the entire process for numerous studies, also drafting the anonymization report and justification table for the reduction requests. Depending on the dossier’s characteristics, Maxer can perform the anonymization process manually and semi-automatically, with the support of software that involves the use of generalization or randomization techniques.

Phase 2 of EMA Policy 0070/2014, not yet implemented to date, provides access to Individual Patient Data by third parties. Maxer has developed an organizational model that regulates and manages access to these important sources of information.