Clinical Overview and Summary are a part of common technical document and contain the interpretation and a synopsis of the results from human with the investigational product. The purpose of Clinical overview is to provide critical analysis of the clinical data and establish beneficial characteristics and potential risks of the medicine.
Our clinical experts can ensure the comprehensive analysis and accurate description of the clinical data with relevant clinical conclusions to support the safety and efficacy your product. Our medical writers can prepare harmonized Clinical modules for you and update or perform a gap analysis of your own Clinical Overview and Summary as well.
