02 Services / Products

Early Access

  • Preparation
    and launch
    of activities

    Drafting and finalization of PUT-RD
    Advice, design and optimization of data collection forms
    Set-up of the AP/AC unit and kick-off meeting
    Development and validation of collection tools
    Drafting of the DMP and the SAP

  • Web application

    Dedicated application and integrated ePRO module (GxP validated)
    HDS hosting in France
    Interfacing to public service platforms (PASREL)
    Dashboard and dedicated reporting

  • Management and analysis of data

    Global package for data-management (DOC, DEV, VAL)
    On mine validation by the remote monitoring team
    Dataviz module dedicated to data review
    Cut-off and editing of TFLs

  • Pharmacovigilance

    Notifications and drafting of narratives
    Drafting periodic reports for the authorities

  • Management of agreements

    Financial agreemment management from template creation to finalization
    Management of sites invoices and payments on behalf of the sponsor

  • + than 90
    early access
    and compassionate use managed since + than
    10 years


+ de 90

accès précoces et compassionnels gérés depuis + de 10 ans