Cardialysis, the 40-year old cardiovascular research organisation, 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 (Rotterdam).
Cardialysis is a cardiovascular research organisation that helped pioneer the field 40 years ago. It is defined as an academic research organisation with contract research organisation 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 organisations, academic institutions, and industry partners, in the execution of clinical trials, from early phase of clinical development up to phase IV or postmarket trials.
The group serves clients from all over the world, including partners across Europe, USA, 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, the European Medical Device Regulation, among others. Cardialysis undergoes rigorous audits from globally renowned organisations on a regular basis that ensure its compliance with regulatory regimes across regions, including the US Food and Drug Administration (FDA).
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 Ernest Spitzer, who currently serves as chief medical officer at Cardialysis, and other private investors, which include dabl Limited, an Ireland-based clinical trials solutions company.
Independence has been a key concern in clinical trials, with the setup 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 centres will remain a pillar of Cardialysis.