About us
We are the medical research infrastructure SLOVACRIN, which supports and implements academic clinical research in Slovakia.
SLOVACRIN
Slovak Clinical Research Infrastructure Network
SLOVACRIN is the national hub for non-commercial clinical trials in Slovakia and has been part of the European ECRIN-ERIC consortium since 2018. It represents a national distributed research infrastructure connecting hospitals, universities and scientific institutions involved in academic clinical research across the Slovak Republic. SLOVACRIN is coordinated by the Faculty of Medicine of the Pavol Jozef Šafárik University in Košice, UPJŠ LF. UPJŠ LF is also the host institution of the European Correspondent. The aim of the national infrastructure is to increase the number and quality of academically initiated clinical trials in Slovakia, using the available capacity and expertise, knowledge, research, and development in the field of medical sciences and building a network of Clinical Trials Units (CTUs) that can provide support for the actual implementation of clinical trials. The establishment of a network of national clinical trial units in healthcare institutions is essential and crucial for the conduct of clinical research.
Clinical trials conducted by academic entities can focus directly on the current needs of the Slovak population in each therapeutic area. When conducting clinical trials within the EU, the same rules apply to all sponsors in terms of conduct, oversight and safety, regardless of whether the sponsor is a commercial entity, pharmaceutical company, or academic sponsor. To ensure an adequate level of performance of academic clinical trials, SLOVACRIN provides specialised service to academic institutions and sponsors in this field.
The SLOVACRIN infrastructure provides a complete service for clinical trials organised by medical researchers. It supports the preparation and implementation of academic clinical trials in Slovakia including multinational trials, provides clinical trial management and complete project management, regulatory activities, monitoring and pharmacovigilance for national and multinational academic clinical trials. It supports investigators and study teams in the preparation and implementation of clinical trials according to Good Clinical Practice (GCP).
On 31.1.2022 the new REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (EU) No 536/2014 from 16 April 2014 on clinical trials on medicinal products for human use entered into force, which represents a fundamental change for the conduct of clinical trials in Europe. The role of the National Hub is to provide information to healthcare facilities and sponsors on their new obligations under the Regulation and the new Clinical Trials Information System, and to assist in the registration of individual healthcare facilities in the European Medicines Agency’s Organisation Management Services (OMS) system. Currently, 23 institutions such as university, faculty and specialised hospitals, networks of private hospitals, universities and scientific institutions have joined the national SLOVACRIN research infrastructure.
ECRIN
European Clinical Research Infrastructure Network
ECRIN is a non-profit intergovernmental organisation that supports the conduct of multinational non-commercial clinical trials in Europe and connects scientific partners with national networks across Europe. Since 2013, ECRIN has had the legal status of a European Research Infrastructure Consortium (ERIC). It currently has 12 member countries (Czech Republic, France, Germany, Hungary, Ireland, Italy, Norway, Portugal, Poland, Spain, Greece and Switzerland) and 1 observer country (Slovakia). Since 2006, ECRIN has been listed in the ESFRI Roadmap as one of the 13 ESFRI Biological and Medical Sciences Research Infrastructures (BMS RIs) and since 2016 it is designated as a “Landmark Infrastructure”. ECRIN is headquartered in Paris and collaborates with European Correspondents across Europe, national networks of Clinical Trial Unit (CTUs), as well as with many European and international partners involved in clinical research. Support for this distributed ECRIN infrastructure is largely coordinated by the European Correspondents. These clinical research and methodology experts are based directly in each member and observer country and are at the core of the unique ability of the research infrastructure to work successfully across borders.
ECRIN offers support and service in the design and implementation of multinational clinical trials. It focuses on academic investigator-initiated trials and provides a variety of services and tools for their preparation and management, such as advice on funding applications and trial design, site selection, logistics, insurance, protocol assessment, risk assessment, regulatory and ethical approval, adverse event reporting, monitoring, data management, statistics, and project management. These tools are critical to the success of a clinical trial, especially in a multi-country context where national legislation and requirements can vary significantly. ECRIN currently has a portfolio of over 60 multinational clinical trials with an average of 6 trials per country. These projects are mostly randomised controlled trials (RCTs) and cover a variety of medical areas. The infrastructure across 12 countries covers a population of 350 million. In addition, it contributes to infrastructure development projects which aim to further develop the European clinical research community and facilitate the implementation of multinational clinical trials. In this way, trials benefit from the results of these projects as they can use the tools and findings that these projects bring.
Organisational structure
The national research infrastructure SLOVACRIN is coordinated and funded by the Faculty of Medicine of the Pavol Jozef Šafárik University in Košice, which is the national scientific partner of ECRIN. The Faculty of Medicine is also the host institution of the European Correspondent and all activities of the national hub are under the responsibility of the Director General.
prof. MUDr. Daniel Pella, PhD.
Director General
daniel.pella@upjs.sk
MVDr. Simona Sonderlichová
European Correspondent
simona.sonderlichova@upjs.sk
doc. MUDr. Štefan Tóth, PhD.
European Correspondent
stefan.toth@upjs.sk
Mgr. Katarína Marcinková
Executive Assistant
katarina.marcinkova@upjs.sk
MUDr. Beata Čečetková, PhD.
Medical Director
slovacrin.skprof. MVDr. Monika Halánová, PhD.
Vice-Dean for Grants, Development and International Relations
monika.halanova@upjs.sk
doc. MUDr. Ján Fedačko, PhD.
Director of MediPark UPJŠ LF
jan.fedacko@upjs.sk
MUDr. Radka Troníčková
Pharmacovigilance
slovacrin.skMUDr. Zuzana Kožlejová, PhD.
PR Manager
zuzana.kozlejova@upjs.sk
European Correspondent
European Correspondents create a link between the national research infrastructure, including the national network of clinical trial units, the ECRIN core team in Paris and other countries. Based in each member and observer country, they represent experts in clinical research and methodology and are the foundation of ECRIN’s unique distributed research infrastructure’s ability to operate successfully in the European space.
For successful implementation of clinical trials, thorough knowledge of the national environment is essential to ensure effective management of international clinical trials. The European Correspondent serves as a unique point of contact for sponsors, investigators, and other partners involved in clinical research. It is part of the National Clinical Trials Network and oversees the implementation of the work of the ECRIN infrastructure in member and observer countries, manages clinical trials portfolio and coordinates national partners. It also ensures smooth coordination, communication, organisation and support during the preparation and subsequent implementation of clinical trials.
European Correspondent ECRIN for Slovakia
MVDr. Simona Sonderlichová
European Correspondent
simona.sonderlichova@upjs.sk +421 55 234 3534
doc. MUDr. Štefan Tóth, PhD.
European Correspondent
stefan.toth@upjs.sk
Partners
The SLOVACRIN National Hub helps to strategically build research infrastructure to support and conduct academic clinical trials and projects. It focuses on medical infrastructures and is a distributed network with the aim to support the establishment of clinical trials departments, increase the number of academic projects and clinical trials with a clear outcome and to ensure systemic funding. This young infrastructure has so far succeeded in linking 23 partners such as university and faculty hospitals, specialist hospitals, networks of private hospitals, universities and scientific institutions.
