Maxer has in-depth expertise in European, UK, and US CTD regulations. Furthermore, it has acquired many years of experience publishing the results of clinical studies on the leading international platforms.
The disclosure team has assets:
- the publication of over 140 studies on the EudraCT platform;
- knowledge of the rules relating to CTD present in EU Regulation 536/2014 and the implementation of the Clinical Trial Information System (CTIS);
- the publication of over 60 studies on the ClinicalTrials.gov platform;
- knowledge of the US legislation on clinical trials (Public Health Service Act, 1944;
- FDAAA 801, 2007; Final Rule, 2017, recent rulings on clinical trials publication.
Should the studies already published in EU Clinical Trial Register present information incompleteness or inconsistencies, Maxer can interact with EMA and with the National Competent Authorities to solve them.
Maxer has developed a Quality Control system for the publication of clinical studies on the main public databases, and can provide a quality check for every uploaded study.