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Clinical Trials Pharmacy

The Clinical Trials sector of the Pharmacy for Internal Use of the CHU Caen Normandie has the main mission of ensuring the pharmaceutical management of experimental health products (drugs and medical devices) for all clinical trials carried out by the investigating physicians of the CHU .

  • Activities


    The Clinical Trials Sector is divided into 2 geographical areas :

    • An EC sector at the “Côte de Nacre” hospital which provides pharmaceutical management of ECs carried out in many disciplines (excluding cancer products requiring centralized sterile preparation in the Cytotoxic Reconstitution Unit ( URC ))
    • An EC sector at the “Clemenceau” hospital which provides pharmaceutical management of oncology ECs requiring centralized sterile preparation in URC .

    The team is made up of trained and qualified professionals who carry out these missions in accordance with Good Clinical Practices, Good Hospital Pharmacy Practices and Good Manufacturing Practices.

    Role of the Clinical Trials Sector

    In externally sponsored trials (industrial, institutional and academic)

    The EC sector team guarantees the quality of the circuit of experimental health products and their traceability at each stage:

    • Receipt of products according to sponsor and protocol specifications;
    • Appropriate storage in a secure room whose temperature is continuously controlled via sensors and a computerized monitoring system (SIRIUS ® ) for each storage space;
    • Nominative dispensation on formal prescription;
    • Sterile preparation if necessary: ​​sterile preparations are made in accordance with Good Manufacturing Practices, either under a laminar flow hood in the sterile room (ISO 8 Controlled Atmosphere Zone) of the “Côte de Nacre” site for CEs excluding oncology, or under the sterile isolator located on the “Clemenceau” site in the URC for oncology CEs;
    • Accounting for returns of treatments dispensed and analysis of compliance;
    • Destruction by an authorized service provider.

    in internally promoted trials (CHU Caen Normandie Promoter)

    The EC sector team is also involved in the pharmaceutical coordination of clinical trials sponsored by CHU de Caen.

    • Early evaluation/expertise of the pharmaceutical and technical feasibility of clinical research projects involving an experimental health product;
    • Development of the circuit of the experimental health product, its budget and evaluation of the possible use of a subcontractor;
    • Relationship with manufacturers on the supply of the experimental product and/or its placebo;
    • Drafting of the part relating to the experimental treatment and its circuit in the study protocol;
    • Drafting of pharmaceutical documents for the investigating centers (pharmacy manual, standard operating procedures, etc.) ;
    • Purchase of drugs for the biomedical research project;
    • Manufacturing operations: packaging, labelling, blinding of study treatments;
    • Pharmaceutical and regulatory release of repackaged/relabelled batches;
    • Shipments of treatments to investigation centers in France;
    • Monitoring of supplies to the investigation centers;
    • Management of relationships with subcontractors / CRO;
    • Management of health alerts / batch recall;
    • Management of the expiration of stocks held by the investigation centers;
    • Participation in implementations in the investigation centers;
    • Regulatory monitoring.

    With more than 220 clinical trials, including 130 currently active trials, the sector annually carries out an average of 580 receipts of experimental health products, 2,300 nominative dispensations and 800 sterile preparations .