PLATFORM PARTNERS PARTNERS FOR INTERNATIONAL CLINICAL RESEARCHS

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1 PLATFORM PARTNERS PARTNERS FOR INTERNATIONAL CLINICAL RESEARCHS Coordonnateurs : Pr Corinne Alberti Pr Éric Vicaut 1

2 WHO ARE WE? Units of Clinical Research APHP Inserm Partner 2 : Lariboisière Partner 15 : Saint Antoine Partner 14 : Pitié Partner 3 : AGEPS Partner 9 : URC-Eco Centers of Clinical Investigation Partner 1 : Robert Debré Epidémiologie Clinique Partner 12 : Cochin Investigation Partner 13 : Bichat Epidémiologie Clinique Partner 4 : Nancy IT Imagerie Nancy Partner 6 : Centres d Investigation Biologiques Partner 10 : Saint-Louis UMR 1153 Mixed Units of Research Partner 8 : Bichat UMR 1137 Partner 5 : Next Step Bioinformatics Partner 7 : Bobigny UMR 1153 Networks of research UMR 1123 Partners 1, 9, 13 Partner 11 : EMIBiotech Partners 1, 11 CEBRIC: Partners 1, 2, 8 10, 13 2

3 Network of Clinical Investigation Centers How are we organized? Medical economics Environment Innovative methodology Network of Clinical Research Units Biobanks Network of competences Rare diseases Medical devices E Pharmacology Large database Pharmacoepidemiology Medical imaging Pharmaceutical products Nutrition INI network European Correspondent 3

4 EXPERIENCE Number of trials Phase 1 and 1-2 n=28 Phase 2 or 3 n=288 Medical device trials n=86 Other interventional trials (surgery, radiotherapy, pysiopathology ) n=69 Number of International trials: 7 including 3 with AGEPS involvement Experience of coordination, monitoring, logistics and analysis of large international trials. ATOLL more than 900 patients 60 centers Europe/USA (sponsor APHP) published in Lancet 2011 ARCTIC 2500 patients 38 centers (sponsor APHP) NEJM 2012, Circulation 2014 INTERACT2 Coordinating Center for Europe NEJM 2013 PRESENCE 570 patients NEJM 2013, ICM2014 PEITHO 1000 patients (sponsor APHP) Favorable Reviewing NEJM 2014 ARUBA 400 patients 65 centers with NIH/Columbia Lancet 2013 ACCOAST more than 4000 patients (independent statistical analysis only) NEJM patients 140 centers Worlwide (Sponsor Georges Institute Australia) 4

5 EXPERTISE ALL SERVICES Organisation Innovative methodology Administrative and regulatory affairs Cost evaluation, Feasibility Operational management Monitoring (risk-based monitoring) Data management ecrf development Pharmacovigilance Investigational products management Biological samples management Biostatistics Big database management Medico-economic evaluation Disease Areas Medical Devices Nutrition Rare Diseases Pediatrics Cardio-vascular Intensive Care Neurologic disease Onco-Hematology Infective disease Publications: over 300 publications in 3 years Quality procedures High level skills Due to our partners in various domains Specialized staff Trained to the highest level Bilingual 5

6 QUALITY ASSURANCE Based on a large number of SOPs Dedicated QA manpower Resources from QA and legal dept. of DRCD Continuous internal formation by workshops programs 6

7 PARTNERS OF THE PARTNERS Corinne Alberti AP-HP URC Hôpital Robert Debré, Inserm CIE 5 et UMR 1123 ECEVE Université Paris Diderot Eric Vicaut - AP-HP URC Hôpital Lariboisière Université Paris Diderot Sylvie Chevret - AP-HP URC Hôpital Saint-Louis, Inserm UMR 717 Université Paris Diderot Karine Chevreul - AP-HP URC Eco Ile-de-France, Inserm UMR 1123 ECEVE Patrice Debré - AP-HP Centre de Ressources Biologiques, CNRS UMR Université Pierre et Marie Curie Céline Feger - EMIBiotech Jacques Felblinger - Inserm CIT 801 Nancy Université de Lorraine Serge Hercberg - Inserm UMR Université Paris 13 Hervé Le Nagard Inserm UMR 738 et Next Step Bioinformatics Alain Mallet AP-HP URC Pitié Salpêtrière Université Pierre et Marie Curie France Mentré Inserm UMR 738 Hôpital Bichat Université Paris Diderot Annick Tibi AP-HP AGEPS Université Paris Descartes Jean-Marc Treluyer - AP-HP URC Hôpital Necker, Inserm CIC-P Centre Necker Université Paris Descartes Florence Tubach AP-HP URC Hôpital Bichat, Inserm CIE 801 et UMR 1123 ECEVE Université Paris Diderot Tabassome Simon AP-HP URC Hôpital Saint-Antoine Université Pierre et Marie Curie 7

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