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Clinical Research Center

The Clinical Research Center is a multi-thematic investigation platform and its mission is to collaborate with all investigators from CHU Caen Normandie. It is made up of an adult part and a pediatric part.

The CRC can carry out all types of clinical research projects.

  • Activities

    The platform

    The CRC is a multi-thematic investigation platform and its mission is to collaborate with all the investigators of the Caen University Hospital. The CRC can carry out all types of clinical research projects:

    • industrial studies;
    • institutional studies not promoted by Caen University Hospital;
    • institutional studies promoted by the University Hospital of Caen.
    The different activities of the CRC
    • Assistance in assessing the feasibility of studies;
    • Assistance in setting up the study;
    • Assistance in the care of volunteers or patients (information on trial procedures and the conduct of visits, signature of consent, evaluation questionnaires, patient log, use of treatment, etc.);
    • Management of the schedules of visits and examinations of volunteers or patients according to the protocol;
    • Performing nursing acts: vital constants, blood tests, administration of treatments, etc.
    • Management of study equipment (reception of laboratory kit, technical sampling, management of sending samples, etc.);
    • Work in collaboration with the CRAs of the promoter and the CRAs investigators of the care service;
    • filling in observation books;
    • assistance with closing and archiving.

    These tasks are à la carte and to be defined before setting up the study.

    All hospital departments can call on the Clinical Research Center to carry out studies in any type of pathology, concerning drugs and medical devices.

    medical support

    The CRC team provides medical and/or logistical support to the investigators for carrying out their study.

    The studies can be carried out on CRC premises or “outside the walls” with the availability of CRC personnel.

    Conduct of a clinical trial

    A clinical trial is divided into 4 phases:

    -phase I trials are the first administration trials of the drug in humans. The objective of this first step is to evaluate the safety of the drug, to determine the dose and frequency of administration to be recommended for the following phases, as well as the fate of the drug in the body.

    -phase II trials make it possible to evaluate the effectiveness and tolerance of the drug and to determine its optimal dose.

    -phase III trials are generally comparative trials which make it possible to evaluate the superiority of the effectiveness of the new treatment by comparing it with the treatment usually used or with a placebo

    -phase IV trials take place after obtaining marketing authorization and marketing the drug.

    When a patient is offered to participate in a clinical trial, their participation corresponds only to a specific phase (I, II, III or IV) of the development of the drug and in no case to its entirety.

    Clinical trials are essential to advance scientific knowledge but also to improve disease management and the patient care pathway.

    In France, clinical trials are highly regulated. Current legislation ensures respect for the rights, interests and safety of the patient.

  • Adults & children

    Adult Clinical Research Center

    It has been authorized by the ARS since its creation in 2007 to conduct early phase trials and trials on healthy volunteers. It has been labeled since 2011 by the DGOS .

    Located on the 13th floor of the Côte de Nacre tower , the premises are secure and approved by an authorization to receive healthy volunteers and patients in the context of biomedical research in adults. The CRC is also authorized to carry out early phase studies.

    The service operates in day or continuous hospitalization according to the terms of the protocols and includes in particular 5 hospital beds divided into 3 rooms, a sampling room, a room for the preparation and freezing of biological samples with suitable equipment.

    Pediatric Clinical Research Center

    Located on the 1st floor of the South building , it has also been authorized by the ARS since June 2020 to receive infants or children in the context of biomedical research, particularly in the early phase.

    The service operates in day or continuous hospitalization according to the terms of the protocols and includes 1 clinical research office, 1 hospital bed, a room for the preparation and freezing of biological samples with the appropriate equipment.