ECRIN European Clinical Research Infrastructure Network.

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1 ECRIN European Clinical Research Infrastructure Network

2 - support to investigators and sponsors in multinational studies Make Europe a single area for clinical research A pan-european infrastructure for clinical research in any disease area Pan-European, distributed infrastructure providing coordinated services to multinational clinical research in Europe: - access to patients and to expertise throughout Europe - despite the fragmentation of health, legislative and funding systems

3 ECRIN development steps ECRIN-RKP ( ) identifying bottlenecks ECRIN-TWG ( ) developing know-how ECRIN-PPI ( ), building the infrastructure and supporting pilot multinational trials ECRIN-ERIC (2012->) operating the ESFRI-roadmap infrastructure for multinational trials ECRIN-Integrating Activity (2012->16) Expanding connections

4 ECRIN-ERIC and scientific partners ECRIN ERIC Scientific Partners (national networks and hubs) Natl hub EC Natl hub EC EC Natl hub Consortium agreements on Provision of services QA costs functional links between EuCo and hub Natl hub Natl hub EC EC ECRIN Core Team EC Natl hub CRC EC EC Natl hub Natl hub

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6 Contracting for services Sponsor Country X ECRIN Correspondent directly or supported by -Adaptation of protocol & procedures -Recruitment of trial sites and Clinical trials facilities Coordinating country ECRIN European Correspondent (country of the sponsor) Country Z ECRIN Correspondent + National Coordination -Finance and contracting -Insurance -Applications (EC, CA, others) -AE reporting -Site monitoring -Reporting -Archiving

7 Why a legal status? Integrated multinational services Responsible for the support to multinational trials Distribution of tasks Distribution of responsibility/liability Distribution of budget ECRIN establishes framework contracts / consortium agreements with scientific partners from countries that are ERIC member/observers, or not services, quality assurance, costs, links with EuCo Single contract with the sponsor for an individual trial Tasks, responsibilities, budget PIC number with third parties in FP7-funded projects Become a sponsor for multinational clinical trials? Act as the sponsor s representative for trials initiated outside EU Contact point in Europe for NIH, etc.

8 Why an ERIC status? Sustainability (a clinical trial lasts 3-5 years, or more) Sustainable funding and commitment from Member States Balance of power: reciprocity among the countries hosting or participating in ERICs Interest from the Commission (I3, other calls, political support) Visibility Not-for-profit, independent assessment of treatments (not a CRO) Selection of projects based on scientific excellence European and International visibility and credibility (NIH, OECD ) Mobility of staff, career development Core team and European Correspondents as ERIC employees Added value in FP7-funded investigator-driven trials??? Eligible as a beneficiary for national funding agencies as service provider in a clinical research project???

9 National networks & hubs Core Team : Centralised Decentralised Ethical Advisory Board External Advisory Board ESFRI-BMS Infrastructures Administrative manager Accounting & FP7 Assembly of Members Director Deputy Director Executive manager Steering Committee Communication Webmaster Auditor Network Committee Legal / contracting Human ressources Assistants Capacity Building Scientific Board secretariat IT certification Scientific Board Core Competences and Quality Manager Operation Manager Quality Assurance audits Monitoring Regulation / ethics Pharmacovigilance Data management Education Insurance Costing EuCos Austria - Belgium Denmark Finland France Germany Hungary Ireland -Italy Poland Spain - Sweden Switzerland United Kingdom

10 ECRIN-IA ( ): structuring pan-european investigation networks

11 Network expansion in ECRIN-IA Iceland Norway Finland Finn-Medi Czech R. The Netherlands Luxembourg Ireland ICRIN UK NIHR-CRN EORTC Denmark DCRIN Germany KKSN Sweden SweCRIN Switzerland SCTO Poland PolCRIN Other world regions Turkey Portugal France Inserm Austria ATCRIN Hungary HECRIN Serbia Spain CAIBER Italy ISS Romania

12 Pan-European structuring of biomedical research rare diseases medical devices nutrition other areas ECRIN pan-european infrastructures providing generic tools and services BBMRI EATRIS pan-european investigation networks developing specific tools and scientific content

13 Romanian Hub ECRIN-IA participant #33: UMFCV University of Medicine and Pharmacy of Craiova The National hub is acting as the single contact point for the coordination of ECRIN services

14 Catalysing factor for ECRIN, based on the high quality research infrastructure and human resources in the 6 traditional universities Network: The six major medical universities in the country (Rectors agreement) Rotating presidency

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