Case Study: Global Cardiovascular Device Company achieves 66% over enrollment target and meets EU MDR post‑market goals six months ahead of schedule with IQVIA

Cardiovascular Device Company Exceeds Patient Enrollment Goals Six Months Ahead of Schedule

Global Cardiovascular Device Company needed fresh post‑market data on five types of cardiovascular grafts and a patch to meet EU MDR post‑market surveillance requirements and support product development. The company sought a global CRO to enroll roughly 1,000 patients and manage multi‑country site activations, but COVID‑19 lockdowns disrupted sites in the UK and Italy — so it engaged IQVIA (IQVIA MedTech) to run the prospective and retrospective non‑interventional study.

IQVIA leveraged its MedTech capabilities — including a global site network, local CRAs, and the IQVIA MedTech Research Management Platform EDC — to replace disrupted sites, accelerate data capture, and complete regulatory submissions across Europe. The study enrolled 1,665 patients (66% over target), finished enrollment six months ahead of schedule, allowed two study arms to be paused (saving time and cost), and delivered compliant data and ongoing 10‑year follow‑up for the sponsor.