The European Clinical Research Infrastructure Network (ECRIN) is a sustainable, not-for-profit, distributed infrastructure with the legal status of a European Research Infrastructure Consortium (ERIC). ECRIN provides support for the development and implementation of multinational clinical research projects in Europe.
ECRIN provides services for the management of multinational trials after having supported investigators and sponsors in the preparation of the trial protocol and funding application. Services during the conduct of the trial include central services and distributed services provided by the ECRIN partners in each involved country. ECRIN primarily provides support to sponsors in investigator-initiated trials to expand their clinical trials beyond the sponsor country into other participating countries; its focus is on independent, multinational academic research as well as trials initiated by biotech and medical device small and medium enterprises (SMEs).
Main tasks in the project
AS WP6 leader, ECRIN will be tasked in the regulatory submissions and interactions with competent authorities and ethics committees for the clinical trial in close collaboration with the sponsor in all participating countries other than the sponsor country. ECRIN will work very closely with the sponsor team and will provide coordinated services across the participating countries supporting the trial: site initiation and set-up; routine on-site monitoring according the monitoring plan and local safety reporting.