Cardialysis Becomes Independent from Erasmus University Medical Center
Rotterdam, 20 April 2023
Cardialysis, the 40-year old internationally renowned cardiovascular research organization, based in Rotterdam, The Netherlands, has reached an agreement to pursue the transfer of its ownership to a Dutch private equity firm and other private investors, establishing independence from the Thoraxcenter, Erasmus University Medical Center.
Cardialysis is a prominent European cardiovascular research organization that helped pioneer the field 40 years ago. It is defined as an academic research organization (ARO) with contract research organization (CRO) capabilities. Cardialysis has contributed to enhance medical therapies globally, in both pharmacological and device interventions, and has successfully executed over 400 clinical investigations. It proudly fosters collaborations with investigators, regulatory authorities, public organizations, academic institutions, and industry partners, in the execution of clinical trials, from early phase of clinical development up to phase IV or post-marketing trials.
The group serves clients from all over the world, including partners across Europe, United States, Canada, China, Japan, Korea, New Zealand, and other countries. Trial management and core laboratory activities are performed in strict accordance with applicable regulations, including Good Clinical Practice (GCP), ISO standards, the European Medical Device Regulation (EU MDR), among others. Cardialysis undergoes rigorous audits from globally renowned organizations on a regular basis that ensure its compliance with regulatory regimes across regions, including the FDA (United States), PMDA (Japan), CFDA (China), and EMA (EU).
With the dynamic regulatory environment in The Netherlands, the owners of Cardialysis, a cooperative of cardiologists from Erasmus University Medical Center, have reached an agreement to transfer the ownership to a Dutch private equity firm founded by Dr. Ernest Spitzer, who currently serves as Chief Medical Officer at Cardialysis, and other private investors, which include dabl Limited, an Irish based Clinical Trials Solutions Company.
Independence has been a key concern in clinical trials, with the set-up of independent committees and independent core laboratories. Furthermore, although the increased regulatory and administrative requirements at Dutch hospitals aim to increase transparency and manage potential conflicts of interest with cardiologists working in the hospital setting and conducting industry-funded research, this newfound autonomy at Cardialysis preserves the overarching mission to drive innovation, research, education, and efficiency, which ultimately benefit healthcare stakeholders around the world and most importantly, underserved patients in need of improved therapies. Academic cooperation, educational activities, and academic ventures with Dutch and international academic and clinical centers will remain a fundamental pillar for Cardialysis.
The independence of Cardialysis has been a long-term objective of the original owners and this exciting transition to become an independent group opens the doors for additional collaborations, nationally, regionally, and globally, enables the organization to achieve greater scale, and sets a new standard for clinical research organizations worldwide.
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