Case Study: European Pharmaceutical Company achieves seamless Phase III EDC data transition in under five months with IQVIA

Leveraging IQVIA’s technical expertise in timely data transition

European Pharmaceutical Company engaged IQVIA to manage a time-sensitive EDC data transition after acquiring a Cushing’s syndrome treatment. The sponsor needed two active Phase III studies (50+ sites across 20 countries) moved from the original sponsor’s proprietary EDC into a Medidata Rave environment within a contractual six-month window, including transfer of study design, clinical data, metadata and user accounts without disrupting ongoing data collection.

IQVIA’s Global Data Management team built a custom data-extraction, transformation and load solution using Rave ODM Webservices API, SAS processing, CDISC ODM messaging, data-comparison and exception-management tools, and CFR Part 11–compliant validation. IQVIA completed the full transition in under five months (more than a month early), cloned both Phase III studies in three days, limited system unavailability to three days (one weekend), and delivered seamless account provisioning and continued data access while accommodating last-minute protocol amendments.