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Medical Writing

 

Preparation of documents required within clinical research, regulatory affairs or for scientific and commercial purposes.

 

Clinical research documents include investigators brochure, study protocols, study reports.

 

Regulatory documents includes documents required for the Common technical document(CTD) clinical and non-clinical sections of the CTD, Clinical Overview, Clinical Summary, Non-Clinical Overview and Non-Clinical Summary. CTD files can be prepared in a suitable format for direct inclusion into the electronic CTD (eCTD). In addition ad hoc reports as required for drug product approval or maintenance can be prepared including clinical and non-clinical expert statements.

 

Scientific documents includes preparation of manuscripts for publications from clinical studies or reviews.

 

Commercial documents could be advertisements and promotion materials such as product brochures, website content, direct mail campaigns. Training manuals for sales representatives or medical information staff.