Case Study: A Global Cardiovascular Medical Device Company achieves on-time, on-budget trial recovery with IQVIA MedTech

Global Cardiovascular Medical Device Rescue Trial

A Global Cardiovascular Medical Device Company engaged IQVIA (IQVIA MedTech) to rescue a mid-study clinical trial that had stalled across nearly 20 countries after the sponsor lost confidence in its original CRO. The sponsor required a rapid mid-study transition and end-to-end services — including project management, clinical monitoring, document management, vendor management and regulatory support — to address a backlog of unmonitored data and resume enrollment of more than 2,000 patients at 125+ sites.

IQVIA deployed a dedicated MedTech rescue team that conducted CRA visits to every site, rebuilt investigator relationships, expedited protocol amendment approvals, and recommended a risk-based monitoring approach to control costs; site assessments were completed within five months (one month ahead of plan). As a result, all sites are active, the study is back on schedule and on budget with two years remaining in the protocol, primary endpoint targets are being met, and the sponsor has awarded IQVIA additional global cardiovascular studies, some of which have obtained FDA approval.