In this interview, Maria Grazia Felisi, Quality Assurance Head and Internal Auditor in Clinical Validation at Biopharmaceutical Findings (CVBF), an Italian CRO, discusses the conduction of multicenter and multinational clinical trials within the context of rare diseases. She provides an overview of the reasons for conducting clinical trials outside Europe and addresses the main challenges encountered, illustrating a practical case in which CVBF was directly involved.
How to conduct a multicenter/multinational clinical trial in rare disease context
The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575.
The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.