Issue 8 2021

10 Acquisition International - Issue 8 2021 Jun21388 The Heart of the Matter The world of research is built on collaboration, but finding the space for that collaboration is not always easy. When the European Cardiovascular Research Institute (ECRI) was founded, it was to perform various studies into the field of cardiology. In Acquisition International’s Global Excellence Awards, the organization was given the 2021 Award for Excellence in Cardiovascular Clinical Studies – Europe. We take a closer look at their fascinating work to see what they do, and how they’ve achieved such amazing success. ounded in 2012, the ECRI was designed to act as a collaborative base of operations for scientists and experts from across Europe to explore the field of cardiology, specifically the performance of investigator-initiated studies. These studies have the potential to revolutionize our understanding of this specialized branch of medicine, opening the doors to a whole new world of opportunity. This non-profit has transformed the way in which cardiology is seen by the world at large, pushing the boundaries of what can be done continually forward. The benefits of ECRI come from the structure of the organization. Through the various processes and systems established, teams can facilitate the design and conduct of clinical trials according to ICH/GCP/ ISO guidelines and standards. ECRI uses a great deal of expertise in these trials, looking to Cardialysis, an established academic and contract research organization, which has executed over 400 clinical studies, in Europe and around the world. The combination of both organizations creates an opportunity for multi-center, multinational investigator-initiated studies. Several multi-center randomized clinical trials with ECRI acting as trial sponsor are currently being conducted by means of scientific grants form leading industries. F As a sponsor of clinical trials, there are four clear responsibilities that make ECRI an innovative partner. These four attributes are what the team focuses on to ensure their work is consistently of the highest quality possible. Firstly, patient safety is paramount. The team carefully designs their clinical trials with expert input from established clinicians and scientists. Prestigious clinical centres and investigators are selected to treat patients to guarantee this, with a system of highly regulated safety reporting procedures. Secondly, the value of data is obvious to a research organization, and to ensuring its integrity is a top priority. ECRI continually monitors the quality and timeliness of data entry, and ensures the continuity of protected databases by hosting these in professional organizations which follow regulations on maintenance of clinical databases. 2021 saw a breakthrough in this respect, making its publication policy public, and therefore a process which can be scrutinized by professionals and specialists from around the world. Thirdly, the team ensures its results are reliable by highly controlled procedures designed to prevent bias among the investigators. By taking deliberate decisions at the start of the research process, it’s possible to bring about a much more independent decision making process. A clear example of this in action is the way in which a clinical trial is monitored by an independent data and safety monitoring board. These expert board assesses the overall safety of a project. It is typically construed by three members, is independent of the ECRI and provides its advice to continue or modify a protocol to the Steering Committees of a study. The final aspect that drives ECRI forward is the timely execution of clinical trials within allocated budgets. Science must lead the research industry forward, but careful management and planning are crucial to reach targets and to generate data that can reliably answer the research questions addressed by a particular clinical trial. Some organizations take a cavalier attitude to this, but the team at ECRI ensures that their work is focused specifically on getting good data in a specific field. The team’s close collaboration with Cardialysis, and with other organizations occasionally participating in ECRI trials, is key to this success. The challenges faced by themedical industry as awhole are numerous, and the work of ECRI contributes to ensuring that cardiovascular clinical studies do not fall behind. As there is less funding currently