CLIENT NEED

A small pharmaceutical company required support to produce a Phase II CSR, including advice on how to template the document and the required content; the client had no in-house writing resource.

OUR SOLUTION

A senior writer with extensive experience writing CSRs was assigned to the project, to ensure that the client had access to as much knowledge of the process as possible. Our group provided the template and content guidance for the document, based on ICH guidelines.

OUTCOME

The senior writer integrated into the client team, leading the report-writing process and offering advice at each stage, to produce a submission-ready Phase II CSR.