Producing Clear, Acceptable Clinical Study Documentation

Why the growing emphasis on medical writing?

With the ever-increasing demand to bring new drugs to market as quickly as possible, the process of writing easily understood clinical study documents is a growing priority for sponsor companies.

Medical writing today is much more than entering data onto a page. Cytel Clinical Research Services specializes in satisfying the growing need for regulatory-acceptable document writing that is familiar with both the emerging clinical design methods and the complexities associated with multi-national, large-scale studies.

Proper Documentation for even the most Complex Trials

Cytel understands the importance of accurate medical writing as a critical component to the clinical development process. Our clinical planning expertise, meticulous attention to detail and legacy of data quality control ensure your supporting trial documentation is as accurate as it is thorough.

Also, our medical writing clients find especially valuable Cytel's ability to react quickly to urgent information requests, especially regulatory inquiries. Handling such unscheduled demands promptly and accurately is all but routine for Cytel Clinical Research experts.

Typical supporting documents include:

• Investigator brochures
• Protocols
• Clinical Study Reports (CSR's)
• Regulatory briefing documents
• Clinical sections of Common Technical Documents (CTDs)
• Integrated summaries
• Abstracts for professional meetings
• Advisory panel meetings - briefing documents, slide sets
• Posters and presentations
• Manuscripts

Contact us to discuss how Cytel's medical writing services can benefit your own research efforts whether routine, complex or critical.