CLINICAL INVESTIGATION CENTRE NETWORK - FOR INNOVATIVE TECHNOLOGY - CIC IT

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CLINICAL INVESTIGATION CENTRE NETWORK - FOR INNOVATIVE TECHNOLOGY - CIC IT
www.cic-it.fr - twitter @cic_it_reseau
  CLINICAL
INVESTIGATION
   CENTRE
  NETWORK
FOR INNOVATIVE TECHNOLOGY
CLINICAL INVESTIGATION CENTRE NETWORK - FOR INNOVATIVE TECHNOLOGY - CIC IT
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)
CLINICAL INVESTIGATION CENTRE NETWORK - FOR INNOVATIVE TECHNOLOGY - CIC IT
• 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
CLINICAL INVESTIGATION CENTRE NETWORK - FOR INNOVATIVE TECHNOLOGY - CIC IT
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
CLINICAL INVESTIGATION CENTRE NETWORK - FOR INNOVATIVE TECHNOLOGY - CIC IT
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
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