Medical Writing

Clinigene has a team of experienced medical writers with scientific expertise to provide high quality clinical study documents (including eCTDs) compliant with ICH guidelines and regulatory requirements. From protocol writing to the final study report preparation, our medical writers collaborate with biostatisticians and project team members to produce comprehensive, submission-ready documents for all stages of clinical development. Every document goes through a rigorous internal quality assurance process ensuring high quality deliverables, on-time. We provide medical writing services as part of the comprehensive clinical trial program or as a stand-alone service.

Our medical writers help you in the preparation of the following:

• Investigator brochure
• Clinical study protocols
• Informed consent forms
• Study assessment questionnaires
• Patient dairies
• Clinical study reports – Phase I to IV
• Abstracts and manuscripts
• Clinical overview and clinical summary (Sections 2.5 and 2.7 of CTD)
• DSMB manuals