European Clinical Research Infrastructure Network (ECRIN)

The European Clinical Research Infrastructure Network (ECRIN, www.ecrin.org) 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 currently has seven Member Countries (France, Germany, Spain, Italy, Portugal, Hungary and Norway) and two Observer Countries (Czech Republic and Switzerland). Additional countries are about to join. ECRIN focuses on multinational academic research as well as trials initiated by biotech and medical device small and medium enterprises (SMEs). It provides support to sponsors in investigator-initiated trials and helps them navigate Europe’s fragmented health and legal systems. Multi-country trials means greater access to patients, resources, and expertise, and, in turn, faster and potentially more robust results.

Role in the TRANSVAC project

ECRIN will provide consultancy services for vaccines clinical trials development. In particular ECRIN will provide all the necessary information regarding the regulatory and ethical requirements necessary for a specific clinical trial. ECRIN will provide access to methodological experts for advice and the review of the clinical protocols. Consultancy will also be offered for the development of funding applications and especially for all aspects regarding the organisation of the management and logistical aspects of multinational clinical trials. In addition ECRIN will provide through its national scientific partners services within the management of the clinical trials and in particular the regulatory and ethical submissions in multiple countries.

Main staff involved in TRANSVAC

Christine Kubiak, Operations Director;

The Facility

ECRIN’s ‘distributed infrastructure’ includes a Core Team based in Paris, France (headquarters) and European Correspondents (EuCos) working in country. ECRIN brings together scientific partners that are national networks of academic clinical trial units (CTUs) and/or clinical research centres (CRCs) located at or affiliated to national universities and hospitals. These CTUs/CRCs have professional staff specialised in clinical research and are highly qualified to conduct multinational clinical trials according to international standards, general and specific regulations applying to clinical trials, and Good Clinical Practices. 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, and after validation of the trial through independent protocol peer-review and logistical assessment. Services during the conduct of the trial include central services (data management through ECRIN certified data centres, central vigilance) and distributed services provided by the ECRIN partner in each country involved (regulatory and ethical submissions and follow-up, monitoring, local vigilance, etc.). ECRIN primarily provides support to sponsors in investigator-initiated trials; its focus is on independent, multinational academic research as well as trials initiated by biotech and medical device small and medium enterprises (SMEs).

TNA or Training provided

ECRIN will provide, for multinational clinical trials, regulatory and ethical submissions in the different countries participating in the trial using the ECRIN national infrastructures in the countries involved. This includes the adaptation of the protocol to national requirements, preparation and adaptation of the patient information sheet and informed consent form, preparation of the documentation required for submission to Ethics Committees and Competent Authorities, submission of the clinical trial Application dossier (CTA) and regulatory follow-up.

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