Clinical Trial Protocol

CROS NT assists clients in preparing a development plan to speed up the process of regulatory approval. This development plan may cover the whole development programme, from pre-clinical studies through post approval drug surveillance and economic outcome trials, or may be limited to a specific project.

CROS NT writes the clinical trial protocol in Italian and/or English according to national and/or international guidelines and regulations. We do the sample size calculation, protocol design and writing. We also review the protocol design with opinion leaders in the specific area of interest.