Clinical Study Documents

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 aspects of key documents can significantly delay project progression.

Give your development programme a competitive edge by using our medical writing and clinical study management teams. They will ensure the rapid and apposite preparation of clinical study documentation. Our team will integrate seamlessly with your clinical groups to facilitate information retrieval and its rapid incorporation within clinical study documents.

Documents we can prepare for you:

• Concept protocols
• Study protocols
• Patient information sheets and consent forms
• Source documentation
• Investigator Brochures
• Clinical Study Reports
• Study Reference Manual
• Thorough QT reports
• Pharmacokinetic (PK) Analyses and Reports (using WinNonLin capability)
• Investigational Medicinal Product Dossier
• Case report forms

Our House Editor works closely with the Medical Writing team to ensure that your documents meet the highest editorial standards at the time of delivery. They can also be engaged on a ad hoc basis as part of your internal approval process.