Meditrial is a leading Clinical Research Organization (CRO) focused on the needs of the MedTech industry. We are proud to serve the most innovative companies in the world. Our staff is recognized by customers and investigators as more expert, trustworthy and responsive – our people get the job done right.
of Clinical Evaluation
AF Ablation Study for Rapid CE Mark
- CE mark for innovative AF ablation devices requires statistically powered studies with appropriate endpoints and follow-up
- Meditrial supported a global medical device companies to collect the CE mark data in less than 2 years
“I wanted to SINCERELY thank you for everything you have done for this project. It is so helpful to know that you are on top of things on the Meditrial's end, and I truly enjoyed working with you! Thank you”
- The Meditrial electronic CRF Catchtrial, was used to collect multicenter data at sites in New Zealand, South America and Europe, allowing the CE-mark application.
- Catchtrial allowed web-based images transfer for DICOM files (TTE, TEE, CT scan), with a Protected health information (PHI) automatic anonymization.
- The system is compliant with US regulation, 21 CFR part 11 .