Regulatory writing

Preparation of the documentation required at each stage of clinical development represents a significant burden on clinical teams. Delay or failure to complete all the necessary key documents can have a significant impact on project timelines.

Give your development programmes a competitive edge by using our medical writing and clinical study management teams. They can integrate seamlessly with your clinical groups to facilitate information retrieval and rapidly incorporate it into clinical study documents.

Frequently requested documents include:

• Concept / study protocols
• Patient information sheets and consent forms
• Clinical study reference manuals
• Investigator brochures
• Clinical trial applications
• Clinical study reports
• Common technical documents

Our in-house editor works closely with the medical writing team to ensure that your documents meet the highest editorial standards. They can also be engaged on an ad-hoc basis as part of your internal approval process.