F-CRIN, TOGETHER TO SUPPORT CLINICAL RESEARCH IN FRANCE F-CRIN, to support Clinical Research in France – 18 March 2014 1 F-CRIN : HOW AND WHY ? A national and European challenge to “Strengthen the most promising of French Clinical Research to Europe” A structure funded by the French government: “Investissements d’Avenir” Call in 2010 20 millions € for 8 years A common collaboration with all national partners of the academic clinical research: INSERM, CNCR (National Committee for Research Coordination), Hospitals, Universities A partnership with Healthcare Industries (ARIIS ) F-CRIN, to support Clinical Research in France – 18 March 2014 2 F-CRIN = a Shared Project A Common Goal The hub for a national access to sponsors and investigators : 1. To support big multicenter academic clinical trials 2. To reinforce the participation and the coordination of European projects by French clinical teams 3. To foster industrial Proof- of-Concept studies in innovative therapies Financial Resources 20M€ F-CRIN, to support Clinical Research in France – 18 March 2014 3 ACTION PLAN : 5 ITEMS 1. Select platforms and investigational networks able to provide support to innovative projects in France and Europe 2. Propose shared clinical trials procedures to the different academic research partners 3. Help the set up and the management of complex European/international projects 4. Professionalize clinical research jobs through training 5. Be the French component of the ECRIN Network F-CRIN, to support Clinical Research in France – 18 March 2014 4 1 GOAL ST Select Platforms and Investigational Networks able to provide support to innovative projects in France and Europe. 2 Platforms 8 INIs Investigators Network Initiative FACT (Cardiovascular) FORCE (Obesity) IMMIDIATE (Auto-immune and Autoinflammatory diseases) 2 Crossectional facilities INI-CRCT (Cardiovascular and Renal) ORPHANDEV (rare INNOVTE (Thrombosis) diseases) I-REIVAC (Vaccinology) TECH4HEALT H (medical NS-PARK (Parkinson’s disease and devices) Movement Disorders) TRIGGERSEP (Sepsis) 5 F-CRIN, to support Clinical Research in France – 18 March 2014 EUCLID (Bordeaux) PARTNERS (Paris) F-CRIN, operational structure providing services to investigators & sponsors to support clinical research projects 6 FINANCIAL CONDITIONS TO ACCESS THE SERVICES A same « Price list » for « Platforms/INIs » An access to excellence which has a price An expected return on investment for F-CRIN (in accordance with the of « Inv.d’avenir ») 7 2 GOAL ND Propose shared clinical trials procedures to the different academic research partners 2 Workpackages involved : – WP3: Coordination of services and portal access – WP4: Tools and common procedures (Quality Assurance ; Management, PV …) F-CRIN, to support Clinical Research in France – 18 March 2014 8 3 GOAL RD Help the set up and the management of complex European/international projects – Alchemist – Sympath F-CRIN, to support Clinical Research in France – 18 March 2014 9 ONGOING IND.PROJECTS IND. EN COURS Project Sponsor Funding Indication Role of FCRIN Conception; Support POC « BN82-451 IPSEN IPSEN + FOX Dyskinésies chez le parkinsonien for management Supervision QA PHRC + Effets du L-ThreoDOPS sur l’HO monitoring; Data MSA-DOPS CHU Toulouse Chelsea de l’AMS management Pierre Fabre Récupération fonctionnelle. Innovation Pierre Fabre PF / FCRIN Etude imagerie et sujet sain AFFIRIS AG (Autriche) AFFITOPE® vaccines , in patient Monitoring, Training, AFFIRIS 009 FP7 with (MSA) Quality control Conception; support to POC « NLX-112 » Neurolixis Neurolixis/FOXDyskinésie Parkinson carry out Conception; Support for management Bumétamide Neurochlore Neurochlore Parkinson Vaccination zona chez les Support for Vaccin Zona/VIH GSK GSK patients VIH management SANOFISupport for Vaccin ClostridiumSanofi-Pasteur PASTEUR management Conception; Support COUPER Bayer Bayer Cohorte embolie pulmonaire for management 10 10 SUPPORT TO EUROPEAN PROJECTS Project NS Park D Devos Thematic PHC 13 Mal Rares S de Kramer CRCT P Rossignol Retreat Frail INNOVTE / Symptoms D Mottier PHC 13 FORCE M Laville PHC 5 PHC 17 Indication Parkinson ; chélation FE Protéomique fœtale et valve urétrales post HTA 3° âge institution Coordinator CHU Lille Inserm Inserm PHC 17 AC et sujets âgés Chir bariatrique sujets âgés CRNH Lyon FACT G Steg INNOVTE / RECIDIVES G Meyer PHC 13 IL2 et IdM Inserm PHC 5 Inserm TRIGGER SEP PARTNERS/ K Chevreul PHC 17 récidive VTE sepsis âgé en réa mHealth CHU Brest Inserm prévention suicide en soins primaires 11 4 GOAL TH Professionalize clinical research jobs through training F-CRIN initiative “European and international projects set -up” “Train the trainer to clinical research for investigators” F-CRIN partnership “Methodology for Clinical research in movements disorders” with “Movement Disorders Society” “Méthodology For Clinical trials in Rare Diseases” with OrphanDev “Clinical research and Innovation in the hospital ” with EHESP F-CRIN, to support Clinical Research in France – 18 March 2014 12 5 GOAL TH As French component of access to the European level , the EuCo EuCo EuCo EuCo EuCo = European Correspondent F-CRIN, to support Clinical Research in France – 18 March 2014 13 ECRIN-ERIC AND ITS PARTNERS ECRIN ERIC not-for-profit organisation MEMBER framework contracts on EC MEMBER provision and costs of services quality assurance single contract with sponsor third parties PIC 948646712 OBSERVER MEMBER Scientific Partners (national networks & hubs) EC Core Team AFFILIATE PARTNER F-CRIN, to support Clinical Research in France – 18 March 2014 NON MEMBER EC NON MEMBER AFFILIATE PARTNER Data centres 14 LE PROGRAMME Comité Essais cliniques Europe France 15 15