Division

THE FEDERAL REPUBLIC OF GERMANY

THE KINGDOM OF SPAIN

THE FRENCH REPUBLIC

THE ITALIAN REPUBLIC

THE PORTUGUESE REPUBLIC

Hereinafter referred to as ‘the Founding Members’

DESIRING to strengthen Europe’s and the Founding Member countries’ position in clinical research in the world, and to intensify cooperation across national boundaries;

CONSIDERING that multinational clinical research is currently hampered by the fragmentation of health and legislative systems in Europe, an obstacle for multinational cooperation in investigator driven, as well as industry-sponsored clinical research (particularly in the biotechnology and medical device sectors), European countries must unlock latent scientific potential and access to patients and expertise, thus strengthening the competitiveness of Europe in clinical science and its attractiveness for the development of preventive, diagnostic and therapeutic procedures — this is of particular importance for rare diseases, paediatrics, personalised treatments, for the development of biotherapy, and for independent clinical trials that are pivotal instruments for evidence-based medicine;

BUILDING on the ESFRI roadmap that identified the European Clinical Research Infrastructure Network (ECRIN) as the distributed infrastructure supporting, based on scientific excellence, clinical research in Europe through information, consulting and services to investigators and sponsors in multinational studies, acting through correspondents hosted in national clinical research hubs and networks, also contributing to the structuring of national infrastructures, harmonising training, tools and practice and high quality standards, fostering transparency and data sharing, promoting a harmonised regulatory system and shared ethical standards;

RECOGNISING that, for each Member country, participating in ECRIN enables the initiation of, and the participation in multinational clinical research projects, taking advantage of the population size of the European Union, therefore strengthens the attractiveness and competitiveness of the national clinical research infrastructure and its ability to support high quality clinical research in line with European standards, with a strong impact on research capacity, on innovation, and on health;

EXPECTING other countries to participate in the activities undertaken together under the following Statutes;