The Larissa consortium is developing a vaccine against Rift Valley fever. CR2O is a partner within this consortium and responsible for the clinical operations. For this phase I study we require a data management and statistics service provider.

The procurement includes the following:

• DMP Creation,

• Review protocol,

• eCRF Specification,

• eCRF Build (Data Entry Screens),

• eCRF Completion Guideline (eCCGs),

• Data Validation Plan (DVP),

• Statistical Analysis Plan (SAP),

• Edit Checks Programming,

• User Acceptance Testing,

• Database migration and Go live,

• Query management,

• Data cleaning,

• Database Lock,

• Statistical programming,

• Randomisation,

• Generation TLF including TLF shells,

• Statistical report generation,

• Topline results (allowing optimal dose selection).