Cardialysis is an independent Clinical Contract Research Organisation (CRO) offering high quality services in the field of cardiology with its focus on Interventional Cardiology, both Devices and Pharmacological Treatments, and Electrophysiology. Cardialysis is recognised for its opinion-leader expertise, strong academic network, statistical expertise, innovative core laboratory technologies and imaging techniques, event adjudication and professional execution of clinical trials.
Based in Rotterdam, the Netherlands, Cardialysis has been facilitating clinical trials for medical devices and pharmaceutical products since 1983 and gained ample experience in phase II (Proof of Concept), phase III and CE-mark clinical trials. All processes are in compliance with Good Clinical Practice (GCP) and with the guidelines of the European Medicines Agency (EMA), Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) and according to ISO standards.
Because of the close relationship with top cardiologists from Europe, in particular from the Thorax Center of the Erasmus MC in Rotterdam, Cardialysis has a clear view on the demands of clinical research in relation to daily clinical practice. Cardialysis trials are published in major scientific journals and presented at international scientific congresses.
Cardialysis has a network of over 1,200 cardiology sites world-wide of which 800 are in Europe. Having established this network, Cardialysis is able to reduce the time for site selection to a minimum without compromising on the quality and patient volume of participating sites.
Cardialysis has core laboratory facilities for the following techniques: Quantitative Coronary Angiography (QCA), Syntax Score, Left Ventricular-Angiography, Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS), IVUS Virtual Histology, Lipiscan, Electrocardiography (ECG), Echocardiography, Multi Slice Computed Tomography (MSCT) and Magnetic Resonance Imaging (MRI). The facilities can also operate as separate entities in trials managed by other organisations.
Furthermore, Cardialysis offers a complete package of services, from protocol design to data management and reporting for clinical trials in cardiology.