Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) is a non-profit research organization founded in 2000 with the mission of facilitating and accelerating the development of drugs with a particular focus on those aimed at the paediatric population and those with rare diseases. CVBF is recognized in Europe for its specific expertise on paediatric and rare disease issues, gained as coordinator/partner in research projects FP6, FP7, H2020, and Horizon Europe, in particular aimed at carrying out multinational trials and creating stable research networks/infrastructures to contribute to the many unmet therapeutic needs plaguing patients with paediatric and rare diseases. Furthermore, CVBF, as a Clinical Research Organization (CRO), supports the success of each phase of drug development by creating value for all the stakeholders involved, combining flexibility, quality and experience with innovative scientific and methodological approaches.