Sam Hamilton Medical Writer
Based in Newcastle Upon Tyne, England, and with over 20 years of experience in the clinical research arena, I offer a professional medical writing consultancy service to the pharmaceutical industry.
I have twelve years of experience in the contract research organisation (CRO) sector, seven of them in medical writing.. Prior to that, I gained 5 years of experience as a clinical research associate (CRA) and clinical project manager (CPM) (Experience). I established myself as a freelance medical writer in October 2006.
I am a postdoctoral virologist, with research experience in the field of cardiopulmonary transplantation. I have a BSc with honours in microbiology and my PhD in gastrointestinal physiology is from the University of Newcastle Upon Tyne (thesis entitled: Duodenal Brunner’s Glands).. My academic background provides valuable analytical perspective essential in my role as a medical writer (Personal Academic Publications).
I have an interest in promoting the public understanding of science and have undertaken voluntary assignments in this area (Science Broadcasting, Writing and Charity Assignments).
I have been an active member of the European Medical Writers Association (EMWA) since 2004 (Sam Hamilton Experience) serving on the EMWA Executive Committee from May 2014 to May 2016 (President [2015 – 2016], Vice President [2014 – 2015]).
I hold the EMWA Advanced (awarded 2013) and Foundation (awarded 2007) Level Medical Writing Certificates.
• Investigator's Brochures
• Clinical Study Protocols (CSPs)
• CSP Amendments
• Clinical Study Reports (CSRs)
• Abbreviated CSRs
• Patient narratives
• Literature reports
• Regulatory submission clinical summary documents
• Regulatory documentation to support product labelling
• Business support
• Dedicated Quality Control
• Standard Operating Procedures/Working Procedures.
Trained in the CRO sector, I understand the need for confidentiality and for working to exacting timelines dictated by regulatory deadlines.
I apply working knowledge of International Council for Harmonisation (ICH) guidelines to prepare high quality documentation to fulfil all your reporting needs (Medical Writing Experience).
My therapeutic experience is diverse and I welcome the opportunity to broaden my range (Therapeutic Experience).
For the range of writing services offered see Services.
To discuss your specific reporting requirements in confidence Contact me.