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 Maxer Disclosure Team:
- submitted over 150 clinical studies on the ClinicalTrials.gov platform
- submitted over 200 clinical studies on the EudraCT platform
- redacted and submitted over 100 Protocols and SAPs for CT.gov
- redacted several registration dossiers for the submission of new products to the EMA CHMP
- wrote over 50 summaries of results, lay results summaries, and lay protocol synopsis for CTIS
wrote expert statements on:
- Clinical Trial Disclosure and Data Transparency: reference legislation on publication of clinical trial results on drugs on EU, UK and USA platforms; sponsor behaviour trends and operational suggestions;
- Regulatory framework (concerning the Responsible Parties’ responsibilities for the publication of the results of interventional clinical trials on drugs and medical devices on ClinicalTrials.gov and on the relevant EU platforms, i.e., EudraCT, CTIS for drugs and EUDAMED for devices in EU).
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.
