Case Study: Leading Medical Provider achieves expedited EUA approval through 3-week adjudication with IQVIA

Leading Medical Provider - Customer Case Study

Leading Medical Provider faced an urgent regulatory challenge during the COVID-19 pandemic: to accelerate adjudication and oversight group establishment for a therapeutic trial so regulatory-requested event adjudication could be completed within three weeks before an interim analysis to support an EUA. They engaged IQVIA (IQVIA CEVA adjudication and oversight group management) to compress a process that normally takes months without compromising committee integrity or regulatory compliance.

IQVIA CEVA deployed a COVID-19 playbook built on five pillars (Adaptive Planning, Key Discussions, Comply but Condense, Accelerate, Execute), using a three-week project start-up, expedited member identification/qualification, condensed documentation, phone follow-ups and DocuSign for signatures. IQVIA established the adjudication committee in three weeks, adjudicated 20 death events with 3 adjudicators, achieved CEC submission-to-final adjudication in 1–3 days and one-week data collection, and supported the client’s EUA approval.