Since 2002 CVBF has been acting as Sponsor and Clinical Research Organisation (CRO) involved in clinical trial execution and it is currently ready to provide its expertise in clinical trials at national and international level, with a specific attention to the field of paediatric and rare diseases. Another important goal has been just reached by CVBF, successfully overcoming 3 days of Good Clinical Practice (GCP) Audit by the Italian Medicines Agency (AIFA).
The activities cover all phases of clinical trials Phase I-IV by providing specific services related to clinical trial management, regulatory and ethics, clinical sites selection and contracting, clinical operations and drug management, data management and monitoring, statistical analysis and medical reporting, pharmacovigilance.
Many activities are conducted in the context of EU funded projects and are focused on the development and application of innovative methodologies in clinical trials for small populations (e.g., rare diseases, paediatrics), as well as the management of interventional, non-interventional, health technology assessment and pharmacoeconomic studies, as well as disease registries.
Here you can find more about CVBF Clinical Research area.