02 Services / Products

Early access and
compassionate use

100+ early access and compassionate use projects managed in over 10 years

  • Preparation
    and kick off

    Drawing up and finalizing the protocol for therapeutic use and data collection
    Guidance, design and optimization of consent forms
    Creation of the EAP/CUP unit and kick-off meeting
    Development and approval of data collection tools
    Drawing up the DMP and the PAS

  • Web application

    A dedicated application including an ePRO module (GxP compliant)
    HDS-certified hosting in France
    Public service platform interfacing (PASREL)
    Dedicated dashboard and reporting

  • Management and analysis of data

    Comprehensive data management package (DOC, DEV, VAL)
    Continuous validation by the unit (remote monitoring)
    Dataviz module dedicated to data reviewing
    TFL cut-offs and editing

  • Pharmacovigilance

    Notification and writing-up of oral statements
    Production of periodic reports for the authorities

  • Management of compensation agreements

    Management of agreements, from draft to signature
    Invoice management and payment of sites on behalf of the client

A few figures


access and compassionate use projects managed in over 10 years


access requests submitted

150 +

periodic reports (oncology, hematology, infectious diseases, COVID 19)