Early Access
Program
-
Preparation
and launch
of activitiesDrafting 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