Case Study: European Medicines Agency achieves compliant clinical data disclosure with Certara

Helping Sponsor Meet EMA Policy 0070 Requirements

The European Medicines Agency (EMA) required a pharmaceutical sponsor to comply with its Policy 0070, which mandates the public disclosure of clinical trial data. The challenge was to meticulously anonymize personal protected data and redact commercially confidential information from a large volume of documents within a strict regulatory timeline. To meet this challenge, the sponsor engaged Certara's Clinical Disclosure team and their specialized services.

Certara implemented a robust solution that combined its team's regulatory experience with automated AI-enabled software and a standardized approach. This allowed them to complete the project ahead of schedule, resulting in the timely submission and acceptance of the large dossier by the EMA. The measurable impact was significant, as the client was retained for two additional submissions, which totaled five times the original submission volume, and the creation of robust documentation enabled even faster turnarounds on subsequent projects.