Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) is a not-for profit scientific organisation, founded in 2000 with the mission to perform research and education in the biomedical field integrating scientific, regulatory, epidemiological, economical and statistical expertise. Members of CVBF are the University of Bari, the Gianni Benzi Pharmaceutical Research Foundation, the Mediterranean Association and the TEDDY Network of Excellence for Paediatric Clinical Research. Moreover, Consorzio per Valutazioni Biologiche e Farmacologiche – Dege e shoqerise se huaj, Albanian Branch Office, has been established in Tirana (Albania) in May 2015 offering one-stop local solutions to investigators, sponsors and research organizations.
CVBF main activities are: development and implementation of new methodologies for clinical trials, particularly those related to small populations (paediatrics, rare diseases). CVBF acts as sponsor and trial coordinator of independent trials and provides services related to clinical trial management including clinical trial design and conduction, ethics and regulatory, pediatric patients’ engagement and advocacy, monitoring and quality assurance, pharmacovigilance and drug management, statistical analysis and clinical reporting.
CVBF is now the coordinator of the EPTRI (European Paediatric Translational Research Infrastructure) project, funded within H2020 for the period 2018-2019, with the aim to design a new paediatric Research Infrastructure (RI) intended to accelerate paediatric drug development including most relevant technological innovations in research for children’s health. Moreover, CVBF is partner in several EU projects related to rare diseases and paediatric clinical research: European Joint Programme on Rare Diseases, c4c pan-European paediatric clinical trial network, PedCRIN Paediatric Clinical Research Infrastructure Network.
CVBF deals with the design and execution of educational programmes and in the creation of e-learning platforms, training activities on medicines development, regulatory issues and clinical research. Moreover, by developing ad hoc informative and educational tools, CVBF aims to increase awareness on the topics of paediatric research and to encourage the participation of children in all the relevant experimental procedures. Regarding the paediatric patients’ engagement and advocacy, CVBF has promoted the creation of the first Italian (in Bari) and Albanian (in Tirana) Young Persons Advisory Group (YPAG).