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.
I was awarded the Nick Thompson Fellowship for services to EMWA in May 2018.
Services
New Clinical trial disclosure consultancy serviceNew "Smart writing" to support public disclosure of clinical-regulatory documents
New Trial results summaries for the layperson
New Clinical trial results summaries posting in registries
Document authoring:
• Investigator's Brochures
• Clinical Study Protocols (CSPs)
• CSP Amendments
• Clinical Study Reports (CSRs)
• Abbreviated CSRs
• Patient narratives
• Literature reports
• Manuscripts
• Regulatory submission clinical summary documents
• Standard Operating Procedures/Working Procedures.
Philosophy
My underlying philosophy is to fulfil client requirements in a timely and cost-effective manner to the highest professional standards. My experience of working with academic groups, large and small contract research organisations (CROs), pharmaceutical and biotechnology companies in clinical monitoring and management as well as in the reporting of clinical trials (Clinical Research Experience), provides wide perspective and understanding of the drug development process.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.
CORE Reference is here
European Medical Writers Association (EMWA) Executive Committee and Board of Directors: President (May 2015 to May 2016), Vice President (May 2014 - May 2015)
I have a proven track record in leadership and strategic management. Over an intensive 2-year period, I initiated, developed and delivered several major projects to support the long-term vision for EMWA, including programmes to retain experienced members and influence our industry: • Expert Seminar Series: delivered expert educational content in a programme of six seminars per conference, tailored for experienced members. May 2015, May 2016• Chair, CORE Reference project. May 2014 – May 2016
• Launched EMWA Regulatory Public Disclosure Special Interest Group (RPD SIG) May 2016
• Launched EMWA Pharmacovigilance Special Interest Group (PV SIG) November 2015.
Client Recommendations
Please see my growing list of client recommendations on my LinkedIn profile page: Sam HamiltonBritish Association Award
British Association award from the Committee for the Public Understanding of Science (COPUS). More...Therapeutic Experience
Allergy | Autoimmune | Brain | Cancer | Cardiovascular | Dermatology |More...