Medical Writing and Publishing
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.
Leveraging knowledge of multidiscipline experts
Our medical writing team works closely with key operational departments including Regulatory, Clinical Operations, Medical Affairs, Biostatistics and Quality Assurance to coordinate and consolidate a fully integrated network of information.
Single point of contact for your project
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 regulatory compliance, data accuracy and consistency within and across documents, providing you with a professional, efficient and cost effective service. We also offer certified translations of all medical writing services for our projects globally.
Full range of services
We offer a complete writing service from support of individual documents to provision of complete medical writing programs and electronic publishing of the final document. Our medical writers have the therapeutic expertise and knowledge to deliver quality materials according to your specifications. We provide these services for both pharmaceutical studies (Phase I - Phase IV) and device studies (pilot, pivotal and diagnostics) over a wide range of indications.
Regulatory Publishing
- Document or submission level publishing
- Disclosure redaction of submission modules and clinical study reports
- Regulatory agency submissions
Clinical studies
- Study protocols, amendments, and administrative changes
- Clinical study reports
- Patient narratives
- Post approval reports
- Development and submission of clinical study outcomes
Other medical writing services
- Investigator brochures
- Aggregate safety reports
- Redaction of MAAs in line with EU clinical trial disclosure Policy 0070
- Clinical Trial Dossiers (IND, NDA, BLA, MAA)
- Manuscripts
- White Papers
- Stand alone Quality Control, including peer review
Educational
- Publications, posters and abstracts
- Promotional and educational material