Name: Czech National Node to the European Clinical Research Infrastructure Network
Institution: Masaryk University
Coordinator: doc. MUDr. Regina Demlová, Ph.D., demlova@med.muni.cz
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CZECRIN is a large research infrastructure for clinically oriented biomedical research focused on investigator-initiated clinical trials. Under the supervision of Masaryk University and in collaboration with St. Anne’s University Hospital in Brno, CZECRIN has created an expert network of clinical trial centres performing independent clinical research in cooperating university hospitals. The development of innovative personalised somatic-cell therapy for oncology, paediatric medicine, and rare diseases is the priority of this large research infrastructure. CZECRIN has several key fields of activity. Its own research and development activities consist of research in clinical pharmacology, including the development of new advanced therapy medicinal products (ATMP). For collaborating users, CZECRIN offers regulatory and knowledge support for investigator-initiated clinical trials, quality assurance/quality control (QA/QC) for accreditation purposes, and practical clinical support consisting of biometry, monitoring, pharmacovigilance, and systematic educational programmes covering the field of clinical research. In accordance with the research priorities, CZECRIN has constructed a manufacturing cleanroom unit operating within the GMP (good manufacturing practice) regime. This manufacturing facility serves for the development and manufacture of personalised medicines used in clinical trials in children’s oncology, children’s diabetology and rare diseases. CZECRIN concentrates on the unique know-how of manufacturing
technologies and the implementation of clinical trials in the field with highly innovative potential. Through professional support, CZECRIN increases the potential for the commercialisation of innovative biotechnological research. The new European regulation concerning clinical trials represents a critical step in the future development of clinical research. Regulation EU 536/2014 significantly changes the system of clinical trials in the EU and has a significant impact on the Czech Republic. Without a functional research infrastructure ensuring research, knowledge, and methodologic support, it would almost be impossible to perform investigator-initiated clinical trials. The future development of CZECRIN, a national node to the ECRIN-ERIC (European Clinical Research Infrastructure Network) European research infrastructure, will facilitate the linking of clinically oriented research infrastructures in the Czech Republic with the application sphere in Europe. On the international level, CZECRIN works very closely with the consortia of BBMRI-ERIC (Biobanking and Biomolecular Resources Research Infrastructure) and EATRIS ERIC (European Infrastructure for Translational Medicine) European research infrastructures.
