Clinical Study Documentation

Starting her career as a CRA, progressing to Project Manager and European Project Team Leader before becoming a Medical Writer, Wendy Kingdom has experience of writing all study-related documents from study conception to completion.

Protocols.

Clinical Study Reports.

Information for Patients Leaflets and Consent Forms.

Other patient information such as instructions for using medication, and appointment cards.

Regulatory summary documents, including clinical summaries and overviews, PIPs, ODDs, clinical expert statements for product license renewals, responses to regulatory questions, investigators brochures and editing of scientific advice documents.

Ethics Committee applications.

Safety narratives.

SOPs.

Manuscripts for publication.