Based on the protocol, ATLANSTAT is in charge of defining the randomization scheme adapted to the study design and writing the randomization section of the protocol.
In the ENNOV CLINICAL tool, the input screens will be developed according to approved functional specifications and the study-specific tool will be put online. During the study, investigators will be able to log in 24/7 and the system will automatically give them the treatment to assign to each new patient. Access management and support will be provided by ATLANSTAT.
The management of treatment kits can be handled by the tool so that enough batches of each product group and dose tested in the study are always available at each investigator site.