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.