Tips for writing an outstanding Clinical Overview
The Clinical Overview (CO) is a vital part of the Common Technical Document (CTD), especially in the EU. When well written, it is an invaluable resource that medical assessors in regulatory authorities use to orientate themselves to understand the scope of, the Applicant’s rationale for and critical issues in the clinical development programme. However, more often than not, a CO is not well written. It is not easy to write a truly critical, yet appropriately supportive, assessment of the data that has to justify the proposed Summary of Product Characteristics (SmPC).