The FP7-funded ECRIN preparatory phase (2008-2011) is the third step of the ECRIN programme, funded by the FP7 Infrastructure programme as the preparatory phase of an ESFRI-roadmap project. It aims to develop a sustainable infrastructure able to support the set-up, conduct, and analysis of multinational trials in Europe.

The objective is to:

• Set up the most suitable legal form for the ECRIN infrastructure.
• Develop a business plan to ensure sustainability.
• Evaluate the organisation of the infrastructure through the conduct of pilot clinical research projects (for more information see support).

After 2011, ECRIN will develop as a sustainable, multinational infrastructure, with an appropriate legal status and a governance involving the Ministries of member states.

WP2 - selection of a legal status in order to allow contract with sponsors, efficient financial management, extension to new member states, and adaptation of the governance structure to allowing efficient decision-making for access of users to the infrastructure. Chair Sven Trelle, Switzerland.

WP3 - preparation of a financial plan to ensure long-term sustainability. This plan will be based on surveys on funding, operation costs and revenues of the infrastructure, and cost of the construction. Chair Jacques Demotes-Mainard, France.

WP4 - evaluation of the needs and existing resources in terms of good manufacturing practice (GMP) facilities (biopharmaceuticals, biotherapy), then establish priorities for their planning and development at the pan-EU level. Chair Maria Ferrantini, Italy.

WP5 - education and training. Train the personnel within the national networks in multinational clinical research projects, with the support of train-the-trainers summer schools and e-learning tools. Chair Michael Wolzt, Austria.

WP6 - extension to other EU member states or to other EU-wide infrastructures. Chair Jacques Demotes-Mainard, France.

WP7 - capacity building programme to help develop the national infrastructure and strengthen the capacity of national coordination to relay the sponsor’s tasks in EU-wide clinical research projects. Chair Xavier Carné, Spain.

WP8 - a quality assurance unit is responsible for the update and upgrade of the quality assurance system, with the support of working parties on ethics, regulation, adverse event reporting, and monitoring. Chair Christine Kubiak, France.

WP9 - communicationwithin the network and with users of the infrastructure, with patients, citizens, and all the relevant stakeholders. Chair Christian Gluud, Denmark.

WP10- specificationsb on the requirements for ECRIN data centres, then implemented through a first call for certification of data centres. Chair Christian Ohmann, Germany.

WP11 - pilot projects. After acceptance by the Scientific Board, multinational clinical research projects are run with the support of ECRIN to investigators and sponsors. The purpose is to assess the validity of the overall organisation and of the quality assurance system of ECRIN, and to refine cost evaluation. Chair Silvio Garattini, Italy.

ECRIN is also a partner in a portfolio of structuring projects in line with its own strategy, including :

• Assessment of the legislative framework for clinical research in Europe (the FP7 ICREL project, Impact on Clinical Research of European Legislation)
• Cross-border connection of disease-oriented research networks (the FP7 ENBREC project, European Network of Bipolar Research Expert Centres)
• Education and training projects (the IMI EMTrain project, European Medicines Research Training Network)