Medical Writing

Kinesis’ medical writing group consists of experts in preparing clinical trial documentation and clinical regulatory submission documents . This highly experienced medical writing team is dedicated to writing Clinical Trial Protocols, Subject Information Sheets, Investigator’s Brochures (IBs), and Clinical Trial Reports. 
Furthermore, our medical writing group prepares, together with a clinical consultant where applicable, CTD modules such as module 2 (Clinical Overview and Clinical Summary) and module 5 (Clinical Study Reports), clinical parts of other regulatory documents, such as a briefing package for meetings with regulatory agencies and pediatric investigation plans (PIP).
Kinesis has its own templates for all clinical trial and regulatory submission documents, but sponsor templates can be used, if preferred.

 

 

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Consultants in drug development

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