Medical Writing

CNS’s Medical Writer, Louise Moore, has been involved in global drug development for over 15 years. With a background in Regulatory Affairs, she has been involved in regulatory strategy for early drug development and in the preparation of Clinical Trial Protocols in the US, European and Australia. She has experience from co-ordination of project teams and obtaining Scientific Advice from FDA and European Authorities, through to preparation of Clinical Study Reports.

Louise has driven CNS’s Medical Writing service for over two years and provides the following services:

• Development of Clinical Trial Protocols from basic concepts through to final execution.
• Preparation of Investigator’s Brochures according to ICH guidelines.
• Preparation of Clinical Study Reports according to ICH guidelines.
• Preparation of Participant Information Sheets and Informed Consents.
• Development of Manuscripts for submission to peer-reviewed journals.

With her extensive Regulatory and Medical Writing background, Louise works closely with CNS’s Clinical Operations team as well as CNS’s BioDesk service.