CLINICAL INVESTIGATION CENTRE NETWORK - FOR INNOVATIVE TECHNOLOGY - CIC IT
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
www.cic-it.fr - twitter @cic_it_reseau CLINICAL INVESTIGATION CENTRE NETWORK FOR INNOVATIVE TECHNOLOGY
www.cic-it.fr - twitter @cic_it_reseau Dedicated to research and innovation on Health Technologies, the CIC-IT network mission is to coordinate the CIC-ITs’ efforts, mutualize their skills; promote all the initiatives that can best respond to the expectations of the research community, the industrial sector and healthcare organizations. What is a CIC-IT? The Network Located in hospitals (CHU – Centres Hospitaliers Uni- A reference in the Health Technology field versitaires), the Clinical Investigation Centres for In- Recent European directives (from 2007, applied in novative Technology (CIC-IT) are open spaces for the French legislation in 2010) focus on respecting research laboratories, industrial companies and standards and norms for the development, evaluation clinicians. and valorization of medical devices. CIC-ITs provide methodological support and technical Building on its expertise in the evaluation of innovative platforms dedicated to innovation and Health Techno- medical devices, the CIC-IT network is at the forefront logy evaluation. to help face the multiple methodological stakes in the necessary steps towards Health Technology The CIC-IT bring innovation up valorization. to the patient’s bed. Three-party collaboration The CIC-ITs’ strength comes from their dual affiliation The CIC-IT network facilitates exchanges and partner to Inserm (Ministry of Research) and the Hospital and ships between fundamental research, clinicians and Health care administration (Direction des Hôpitaux et industrials. de l’Organisation des Soins – Ministry of Health). A complementary network The CIC-ITs work on complementary topics. Besançon focuses on microtechniques, Bordeaux on Clinician Testimony biomaterials, Garches on motor disability compen sation devices, Grenoble on computer-assisted “I want to thank everyone who participated to the surgery, Lille on biosensors and e-health, Nancy on project’s writing in a record time. The good will and magnetic resonance imaging, Rennes on implantable enthusiasm have been remarkable all along the project. Many thanks for coordinating these actions.” cardiac prosthesis and monitoring systems and Tours Pr Jean-Charles LE HUEC on ultrasound and radiopharmaceuticals. (PU-PH, CHU de Bordeaux) Researcher Testimony “In less than five years, the CIC-IT Network has built a true synergy between research, Industrial Testimony innovation and clinical studies. This year they “…Well done for your tenacity that enabled manage to obtain a National Call project.” to collect the maximum amount of data. Jean-Louis COATRIEUX Thanks for all your efforts.” (DRE Inserm, PhD.) Maurice Bagot d’Arc (Sr Medical Affairs Director – Asia Pacific – R & D Global Bio surgery – BAXTER BioSciences)
• Technical evaluation www.cic-it.fr - twitter @cic_it_reseau • Ergonomic evaluation • In vivo evaluation • In vitro evaluation • Research/Upstream advice • 1st prototype PrecLInIcaL eVaLuatIon MIssIons • Principle of the innovation • Regulatory study ProoF oF concePt • Foster translational research research and the emergence of technological innovation. • Carry out demonstrative studies “Accompany the biomedical innovation and studies proving clinical concepts. Translational from the bench to the bed.” • Perform technical, ergonomic, pre-clinical research and clinical evaluation of Health Technologies. • Promote access to a high-tech university PatIent hospital environment for the private-sector industry. • Evaluation of basic need • Evaluation of “medical benefit” cLInIcaL eVaLuatIon • Take part in training in Health Technologies. FeasIBILItY KeepInG In MInd THe oBjeCTIve VaLorIZatIon • Drafting protocols • Seeking funding and call for tender’s submission oF THe “paTIenT-BeneFITs” • Industrialization • Cost evaluation MaturatIon Process oF a MeDIcaL • Recommendations • Publications • Submission helps for regulatory authorities • Setting up the study and data collection DeVIce: CIC-IT’S INTERVENTIONS • Supporting scientific paper’s writing the netWork aDDeD VaLue: keY Facts coMMon VaLues • 8 centres; • 8 excellence platforms, 8 fields of expertise; A quality approach CE Marking • 114 industrials (clients/partners); The quality approach developed in each centre is The Ce marking is the witness of the conformity to the • 116 associates; coordinated by the network through: essential health and safety requirements written into european • 265 clinical studies in progress; - Setting up valorization conventions and agreements; directives. • Numerous partnerships with public or private organizations. Clinical data have been required since march 2010, in France, - sharing practices, technical resources and supply chain irrespective of the medical device class, in order to obtain the approaches; CE marking of all medical devices (according to the 2007/47/ - sharing databases and methodologies for evaluation. CE directive, which amends the 93/42/CEE directive for medical devices and the 90/385/CEE for active implantable An investment in e-learning medical devices). Copyright photo : Inserm / Patrice Latron Since 2009, the network has been offering a remote training In this new situation, the CIC-ITs – thanks to their metho- program on Health Technology innovations. dological, regulatory and supply-chain expertise on clinical each centre accommodates interns and phd students: investigation in medical devices – are the privileged interlo- physicians, clinicians, engineers, Human Factor experts… cutors for industrial manufacturers who want to establish a who have the opportunity to work on very innovative projects. proof of concept and clinical evidence of their innovative me- dical device. A National and International visibility The network is a privileged partner of national and european research networks. CONTACT: Régis Beuscart, National CIC-IT Network Coordinator - 150/154 rue du Dr Yersin - Institut Hippocrate - Pôle Eurasanté - 59120 LOOS - Phone: +33 3 20 44 60 38
BesanÇon cIc-It BorDeauX cIc-It MICROTECHNIQUES BIOMATERIALS FOR HEALTH AND IMPLANTABLE MEDICAL DEVICES BESANÇON CHU BORDEAUX CHU UNIVERSITY OF FRANCHE-COMTÉ UNIVERSITY OF BORDEAUX SEGALEN BERGONIÉ INSTITUTE The CIC-IT steps in the design and evaluation of new The CIC-IT integrates in its approach, the validation and medical devices requiring precision techniques or assessment of biomaterials and implantable innovative miniaturization. medical devices in terms of biocompatibility and clinical applicability. coorDInators: Lionel pazart and emmanuel Haffen coorDInators: Laurence Bordenave and Marlène durand contact: contact: CHU de Besançon plateforme Technologique d’Innovation Biomédicale (pTIB) 25000 Besançon Hôpital Xavier arnozan France avenue du Haut Lévêque cic-it@chu-besancon.fr 33600 PESSAC France + 33 3 81 21 86 22 www.fc-santé.fr/cicbt-besancon cic-it@chu-bordeaux.fr +33 5 57 10 28 62 www.cic-it-bordeaux.fr Garches cIc-It (ParIs) GrenoBLe cIc-It MOTOR DISABILITY MAXIMIZATION OF THE EFFECT COMPENSATION DEVICES OF TARGETED EXPERT THERAPIES AP-HP CHU DE GRENOBLE UNIVERSITY OF VERSAILLES UNIVERSITÉ JOSEPH FOURIER The CIC-IT focuses on three main specific orientations in The CIC-IT supports the whole process of maturing me- neurological handicap and motor disability: mobility, com- dical devices, mainly in the field of Computer aided Medi- munication and respiratory deficiency. cal Interventions (CaMI). coorDInators: coorDInators: djillali annane, david orlikowski and Frédéric Barbot philippe Cinquin and alexandre Moreau-Gaudry contact: contact: 104 Bd Raymond Poincaré pôle de santé publique 92380 GARCHES DMIS – CHU de Grenoble France 38043 GRENOBLE Cedex 9 frederic.barbot@apr.aphp.fr France +33 1 47 10 44 77 cic-it@chu-besancon.fr www.cic-it-garches.fr + 33 4 76 76 92 60 www.cic-it-grenoble.fr
LILLe cIc-It nancY cIc-It BIOSENSORS AND E-HEALTH: MRI EQUIPMENT, METHODOLOGY INNOVATION AND USABILITY AND TECHNIQUES LILLE CHRU NANCY CHU UNIVERSITY OF LILLE 2 DROIT ET SANTÉ UNIVERSITY OF LORRAINE The CIC-IT is dedicated to technological innovation in The CIC-IT’s main role is to support innovative medical biosensors and eHealth, as well as to usability evaluation devices, new sequences or MrI acquisition techniques. of health technologies thanks to its Usability Lab. It also develops and validates new techniques for the ac- quisition and processing of MrI images. coorDInators: régis Logier and sylvia pelayo coorDInators: jacques Felblinger and Cédric pasquier contact: contact: 150/154 rue du Dr Yersin CHU de nancy Brabois Institut Hippocrate - pôle eurasanté 4e étage – Tour Drouet 59120 LOOS rue du Morvan France 54511 VANDOEUVRE-LES-NANCY nathalie.zenani@univ-lille2.fr France + 33 3 20 44 67 45 cic-it-nancy@chu-nancy.fr www.cic-it-lille.fr + 33 3 83 15 78 23 www.cic-it-nancy.fr rennes cIc-It tours cIc-It CARDIAC PROSTHESES ULTRASOUNDS AND AND MONITORING SYSTEMS RADIOPHARMACEUTICALS RENNES CHU TOURS CHRU UNIVERSITY RENNES 1 FRANÇOIS RABELAIS UNIVERSITY The CIC-IT focuses on intelligent communicating implan- The CIC-IT is dedicated to two major sectors of medical table cardiac prostheses, as well as monitoring systems imaging: ultrasounds and radiopharmaceuticals. dedicated to pediatrics. coorDInators: coorDInators: Frédéric patat and Catherine roussel philippe Mabo and Guy Carrault contact: contact: CHU de Rennes / Centre cardio penumologique Hôpital Bretonneau rue Henri Le Guilloux 2 Bd Tonnellé / Bâtiment B1A, 1er étage 35033 RENNES Cedex 37044 TOURS Cedex 9 France France guy.carrault@chu-rennes.fr v.frappreau@chu-tours.fr philippe.mabo@chu-rennes.fr +33 2 47 47 97 90 +33 2 99 28 25 09 www.cic-it-tours.fr www.ltsi.univ-rennes1.fr/cit
You can also read