Our team of dedicated, professional medical writers can provide a complete writing service to clients around the globe, spanning the generation of individual documents to extensive medical writing programs. We ensure that the medical writer assigned to each project team has the required document and therapeutic expertise to fulfill each sponsor's needs, including:

• Regulatory Writing
• Clinical study reports
• Study protocols, amendments, and administrative changes
• Patient narratives
• Investigator brochures
• Aggregate reports (ASRs, PSURs, IND update reports)
• Product labeling
• Regulatory agency submissions

• Publications, posters, abstracts
• Promotional and educational material

Our medical writing team works closely with key operational departments - Medical Writing and ICON Biometrics, Medical Affairs, Quality Assurance, Regulatory and Clinical Operations -  in order to access a fully-integrated network of information.

Each project is assigned a dedicated medical writer who is responsible for managing the writing process and a communication plan is agreed with the sponsor. Our rigorous QA process ensures all contractual obligations and regulatory requirements are met and our global projects are supported by the ability to provide certified translations of all medical writing services.