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

• Randomization

• Generation TLF including TLF shells

• Statistical report generation

• Topline results (allowing optimal dose selection)