Since 2002 CVBF is involved in clinical trial execution in the paediatric and rare disease fields. The activities cover all phases of clinical trial development and management, which CVBF performs both as a Sponsor and as certified Contract Research Organisation (CRO). Indeed, CVBF is accredited as a non-profit promoter of clinical trials by the Italian Medicines Agency (AIFA) and by the European Medicines Agency (EMA) and as a Contract Research Organisation – CRO by AIFA, pursuant to and in accordance with the Italian Ministerial Decree 15/11/2011. In the context of the EU-funded projects (DEEP; CloSed; GAPP; NEOVANC), CVBF is particularly involved in the management of ethical procedures for multi-national paediatric trials in order to guarantee adequate ethical standard in EU and non-EU countries. In particular, CVBF participated in the international discussion and public consultation on the revision of Directive 2001/20/EC and on the proposal for the new EU Regulation on Clinical Trials.
With reference to the “Innovative models for clinical trials”, CVBF has also developed research activities aimed to develop and improve scientifically, clinically and logistically plausible alternatives to the classical designs for paediatric clinical trials. Such results have been included in training courses and peer-reviewed publications and have been applied in paediatric clinical trials.
Specifically, the activities of the Consortium can be grouped in the following areas:
- medical writing
- planning and clinical trial management
- regulatory activities and ethics
- data management
- monitoring and auditing
Moreover, CVBF is a member of the Italian Association of CROs (AICRO) and of several scientific networks promoting clinical trials.