Clinical Study Report

The clinical study report (CSR) is a crucial document in the drug development and regulatory submission process. According to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline E3, a CSR is an integrated report of a study of any therapeutic, prophylactic or diagnostic agent in which the clinical and statistical description, presentations and analyses are provided in a single report, incorporating tables and figures into the main text of the report and in appendices. To ensure prompt delivery of high quality CSRs, a medical writer needs to both understand regulatory requirements and have the ability to decode the many aspects of the project knowledgebase. We provide here some key learnings from the Niche medical writing team, who have been writing CSRs for the pharmaceutical industry since 1998.