40 years of collaborations in Cardiology
Cardialysis is a leading Cardiovascular Research Organization with an exclusive focus on Cardiology, providing the full range of clinical research and cardiovascular core laboratory services. Cardialysis was founded in 1983 as a spin-off of the Thoraxcenter, Erasmus Medical Center, and is recognized for its key-opinion-leader network, strong academic involvement, and in-depth methodological expertise. In the past decades, Cardialysis has developed full-service clinical operations capabilities tailored to this dynamic area, strengthened by professionals with academic background and advanced understanding of management and execution of clinical trials. The world’s leading medical device, biotechnology, and pharmaceutical companies have been collaborating with Cardialysis across more than 400 clinical trials. In this way, Cardialysis has contributed to bring multiple improved cardiovascular therapies to hospitals around the world, improving patient outcomes and quality of life.
Structural Heart Core Lab
The Cardialysis Structural Heart Core Lab provides the perfect partner in conducting transcatheter therapies clinical trials (e.g. TAVR, TMTT). Over the past few years thousands of imaging data from patients enrolled in several registries and clinical trials have been successfully analyzed and adjudicated by the Cardialysis Core Lab. These data are used for CE mark and FDA submissions.
Investigator Initiated Studies
The European Cardiovascular Research Institute (ECRI) offers a platform for the design and conduct of international investigator-initiated clinical trials. ECRI acts as Sponsor ensuring compliance with ICH GCP guidelines and regulatory standards. Trial activities are executed by Cardialysis alone or in collaboration with renowned research organizations world-wide.
Monitoring Services
Cardialysis offers a consolidated monitoring network across Europe. Our clinical research associates ensure timely activation of investigational sites, high-quality data review and effective interaction with sites. With >1400 sites monitored and >200,000 patients included, Cardialysis has established a significant track record in site management.