Early access and
compassionate use
100+ early access and compassionate use projects managed in over 10 years
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Preparation
and kick offDrawing 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