Tender Specifications for the Support of three Phase IV Studies in Europe with QIV Vaccine Against Influenza

A Clinical Research Organisation (CRO) is being sought to support three Phase IV clinical studies that will take place as part of an EU-funded project. The studies will be conducted with a QIV vaccine in vulnerable populations, including three age groups: 1) The elderly ≥ 60 years; 2) Children 3-8 years; 3) Infants 6 months. In Europe, three research institutions will be involved (University of Antwerp, University of Bergen, Université Libre de Bruxelles), which will be responsible for recruiting the respective age group. To support the three clinical centers in their studies in Europe, the following services are required from a CRO: clinical data management, clinical monitoring and SAE reporting.