ECRIN-PPI · European clinical research infrastructures network for clinical trials and biotherapy - preparatory phase for the infrastructure

European clinical research needs an integrated and distributed infrastructure able to provide efficient support to multinational clinical trials, taking advantage of the European population and competencies, unlocking latent expertise and patients scattered across the EU member states. ECRIN (European Clinical Research Infrastructures Network) is designed to bridge the fragmentation of clinical research in Europe through the connection of national networks of clinical research centres and clinical trial units. Participants are currently Austria, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, Switzerland, the United Kingdom, and the EORTC. It will provide integrated, ‘one-stop shop’ services to investigators and sponsors in multinational studies (patient recruitment and investigation, data management, GMP manufacturing of biotherapy products, quality assurance, monitoring, ethics, regulatory affairs and adverse event reporting). With this objective, the preparation phase will consist of - WP2: selection of a legal status and of the governance structure - WP3: agreement on a financial plan leading to a long-term sustainability during the construction step and the operation phase - WP4: survey on needs in terms of GMP facilities for biopharmaceuticals and biotherapy, and their design. - WP5: education programme for multinational clinical studies - WP6: extension to other EU member states - WP7: capacity building to help national networks fulfil the sponsor’s tasks - WP8: update and upgrade of the quality assurance system - WP9: internal and external communication - WP10: accreditation of data centres - WP11: support to pilot projects Users will be investigators and sponsors in the academic and SME sector. Participants will be the national coordination of clinical research infrastructures, and national ministries and funding agencies in order to reach an agreement ensuring the long-term sustainability of the infrastructure.