Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) is a non-profit organization whose mission is to perform research and education in the pharmaceutical field integrating regulatory, methodological, ethical, clinical, epidemiological, economical and statistical expertise.
It is a consortium between Università degli Studi di Bari ‘Aldo Moro’ (UniBA), Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus (FGB), TEDDY – Network of Excellence for Paediatric Clinical Reserach (TEDDY) and Mediterranea – Associazione per lo sviluppo locale (MEDITERRANEA).
CVBF has a longlasting experience in performing paediatric clinical trials where it acts as sponsor and project coordinator of independent trials. CVBF also provides specific services related to clinical trial management, data collection and storage, clinical operations, drug management, monitoring and quality assurance, clinical study reports and statistics and is registered in EudraVigilance to perform pharmacovigilance activities.
CVBF has also developed a European Paediatric Medicines Database (EPMD) including information on medicines approved for children by EMA (indication, dosages, by age populations, studies and trials, etc).
CVBF has significant expertise in the project coordination, conducting research activities mainly in the context of national and EU funded projects and being Coordinator of two FP7 projects (DEEP, GAPP) and Partner in many other projects funded by the European Commission (DG-Research and DG-SANCO).
Currently, it is the Coordinator of EPTRI (European Paediatric Translational Research Infrastructure), funded as a Horizon 2020 project, a new complementary Research Infrastructure (RI) in the context of the existing RIs intended to putting together and networking all the available competences and technologies useful to enhance paediatric research in paediatric medicines from drug discovery and early development phases to be translated into clinical phases and medicines uses. To harness efficiency in delivery of paediatric research activities and services, EPTRI will act as a ‘Paediatric Common Service’ in the ESFRI (European Strategy Forum on Research Infrastructures) scenario and will cover all the different scientific domains grouped in the following five thematic platforms: 1. Pediatric Medicines Discovery and Preclinical Studies; 2. Biomarkers; 3. Paediatric Pharmacology, 4. Formulation Science, 5. Underpinning Paediatric Studies.
The CVBF associate organisation University of Bari “Aldo Moro” is a large University that offers a wide panel of training activities in the scientific field. Department of Pharmacy – Drug Sciences is actively involved in the project since it offers a wide expertise and technical equipment for the production and optimisation of different pharmaceutical formulations, also performing the required European Pharmacopeia assays. Moreover, a computational laboratory for molecular modelling of drug and excipients is also active.