Clare Dixon founded CEDIX Medical Writing Ltd after 15 years working for a large pharmaceutical company.  She spent 5 years as a preclinical research scientist and 10 years as a medical writer working in Medical Communications.  During her time in the Medical Communications group Clare gained a comprehensive understanding of regulatory and ethical guidelines surrounding clinical studies and regulatory submissions (including GCP, ICH, Declaration of Helsinki, and relevant FDA, EMA, PMDA and International requirements as well as disease-specific guidances).  She gained experience in authoring documents at all stages of the clinical development process, from first-time-in-man studies to post-submission regulatory defence, including: Clinical Study Reports; patient safety narratives; Investigator Brochures; Investigational Medicinal Product Dossiers; briefing documents; Paediatric Investigational Plans; Common Technical Document summaries, overviews and narratives; regulatory responses; and documentation of clinical strategy.  In addition Clare has experience in compiling summaries of clinical trials for clinical trial disclosure.

Since becoming a freelance medical writer Clare has gained experience in writing promotional material and has received training on the CONSORT, GPP2 and ICMJE guidelines.

Clare is a member of the European Medical Writers Association (EMWA) and NetworkPharma, and keeps abreast of the latest developments and issues surrounding medical writing.

Therapeutic area experience

Clinical experience in the following areas:

• Oncology (prostate, breast, non-small cell lung, AML, CML, glioblastoma)
• Inflammation (rheumatoid arthritis, osteoarthritis)
• Respiratory (COPD, asthma)
• Cardiovascular (antithrombosis, diabetes)
• Pain (post-surgical, chronic)
• Infection (antiviral)
• Neuroscience (schizophrenia)

plus a proven ability to pick up new therapy and disease areas quickly.