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Clinical Trial Pharmacy

TheClinical Trials sector of the Pharmacy for Internal Use at the Caen Normandy University Hospital has the main mission of ensuring the pharmaceutical management of experimental health products (medicines and medical devices) for all clinical trials conducted by the investigating physicians of the University Hospital.

  • Activities

    Organization

    The Clinical Trials Sector is divided into 2 geographical areas :

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

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

    Role of the Clinical Trials Sector

    In externally sponsored trials (industrial, institutional and academic)

    The EC sector team is responsible for ensuring the quality of the investigational health product supply chain and its traceability at every stage:

    • Receiving the products according to the specifications of the sponsor and the protocol;
    • Appropriate storage in a secure room with continuously controlled temperature via probes and a computerized monitoring system (SIRIUS®) for each storage space;
    • Dispensing by name on a protocol order;
    • Sterile preparation if necessary: ​​sterile preparations are carried out 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 ECs outside oncology, or under the sterile isolator located on the "Clemenceau" site in theURC for oncology ECs;
    • Accounting for returns of dispensed treatments and analysis of compliance;
    • Destruction by an authorized service provider.

    in internally sponsored trials (Caen Normandy University Hospital Sponsor)

    The EC sector team is also involved in the pharmaceutical coordination of clinical trials for which the Caen University Hospital is the sponsor.

    • Early assessment/expertise of the pharmaceutical and technical feasibility of clinical research projects involving an investigational health product;
    • Development of the experimental health product circuit, its budget and evaluation of the possible use of a subcontractor;
    • Relationship with manufacturers regarding the supply of the experimental product and/or its placebo;
    • Drafting the section relating to the experimental treatment and its circuit in the study protocol;
    • Drafting of pharmaceutical documents for investigator centers (pharmacy manual, standard operating procedures, etc.) ;
    • Purchase of medications for the biomedical research project;
    • Manufacturing operations: packaging, labeling, blinding of treatments under study;
    • Pharmaceutical and regulatory release of repackaged/re-labeled batches;
    • Shipments of treatments to the investigating centers in France;
    • Monitoring of supplies to investigator centers;
    • Managing relationships with subcontractors / CRO;
    • Management of health alerts / batch recalls;
    • Management of expiry dates of stocks held by the investigating centers;
    • Participation in the setup of facilities in the investigating centers;
    • Regulatory monitoring.
    Achievements

    With more than 220 clinical trials, including 130 currently active trials, the sector annually achieves an average of 580 receipts of investigational health products, 2300 named patient dispensations and 800 sterile preparations.