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 that you are provided with a professional, efficient service. We offer certified translations of all medical writing services for our projects globally.
Full range of services
We offer a complete writing service spanning 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 writing
- Regulatory agency submissions
- Clinical study reports
- Study protocols, amendments, and administrative changes
- Publications, posters, and abstracts
- Promotional and educational material
Other medical writing services
- Investigator brochures
- Patient narratives
- Aggregate reports
- Product labelling