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Medical Writing & Publishing
Specialist services to support your clinical trial
Specialist services in medical writing to support your clinical trial
Medical and regulatory documentation developed by experienced medical writing teams plays a pivotal role in the success of a clinical research project. Our professional service encompassing all regulatory requirements will be tailored to your needs.
Our medical writing team works closely with key operational departments including Biostatistics, Medical Affairs, Quality Assurance, Regulatory and Clinical Operations to access a fully integrated network of information.
Single point of contact
Each project is assigned a medical writer who is responsible for managing the writing process. A communication plan is drawn up to ensure you are aware of progress against timelines.
Our rigorous quality assurance process ensures all regulatory requirements are met and thatyou are provided with a professional, efficient service. We offer certified translations of all medical writing servicesfor our projects globally.
Full range of services
We offer a complete writing services panning from individual documents to extensive medical writing programs. Our medical writers have the therapeutic expertise and knowledge to deliver quality materials according to your specifications.
Regulatory publishing
- Regulatory writing
- Regulatory agency submissions
Clinical studies
- Clinical study reports
- Study protocols, amendments, and administrative changes
Educational
- Publications, posters, and abstracts
- Promotional and educational material
Other medical writing services
- Investigator brochures
- Patient narratives
- Aggregate reports
- Product labelling
With ICON’s quality management system, you can have confidence in your documents. We leverage technology and automation to increase efficiencies and build quality review and approval milestones in our processes.
ICON is technology agnostic, using a range of software for Medical Writing, including: EndnoteX8, Sage-based templates, PerfectIT, PleaseReview, Workshare, Veeva Vault, JMP Clinical, Protect ARARA.
ICON also provides a range of Medical Communications and Creative and Digital Services to support product brand success.
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