1. Innovation, translational research
Medicine is an extremely dynamic economic and social area of the modern world. Medical innovations emerge every day in different parts of the world. In the R&D Centre we cooperate with entities that are determined to launch innovative solutions, especially in the area of cardiology, cardiac surgery, vascular surgery, rehabilitation and telemedicine. We have competence, knowledge and capabilities to support the process of innovation at every stage, from ideas, through pre-clinical and clinical trials, to presentations at international conferences and congresses. We consult the assumptions of each project, we advise and optimize the planned course of study, with a view to introducing a solution to clinical practice.
2. Formal aspects
We support obtaining research authorizations from relevant institutions (Ethical Committee for Experiments on Animals, Bioethics Committee, Office for Registration of Medicinal Products). The research projects are carried out in accordance with the standards of the Good Laboratory Practice and the Good Clinical Practice, ensuring data reliability through high quality and repeatability of the obtained results.
3. Pre-clinical trials
Much of the medical innovations require detailed pre-clinical trials, from biocompatibility testing to implantation of prototype medical devices and verification of the safety and feasibility of procedures. At the Experimental Laboratory of the R&D Centre we provide opportunity to conduct research in accordance with all requirements and standards applicable in Poland, the European Union and the USA.
4. Clinical trials
After the completion of pre-clinical phase, we provide a unique opportunity to continue the study in the experienced clinical centers of American Heart of Poland and collaborating centers. First-in-Man studies are the first step in obtaining a CE Mark and then introducing a product into the market, followed by a full, multi-center clinical trial. Before the start of the clinical trial, a test protocol is prepared and training is provided to the research team. The following persons are involved in implementation of a study: lead investigator, investigator, clinical trial coordinator, department head, nurse staff, technical staff. The course of the study is monitored by an independent entity and verified for adverse events. At the end of the study, a final report summarizing the course and the results of the study is created.
5. Implementation and dissemination of results
Innovations undergoing the full cycle from concept to clinical application require further steps to be successful in the market. R&D Centre staff conducts training of physicians concerning the use of new medical devices and the implementation of new surgical techniques. It is worth pointing out that the results of research conducted in the R&D Centre are widely published in prestigious international journals and presented during conferences and congresses.