We are a small team combining virologist, statisticians, quality and regulatory experts and superb client focussed specialists with a wide range of skills and experience. We love what we do, and we do it with passion. We look forward to working with you.
Founder Virology Consult Ltd
After starting his post-doctoral career at University of London and Retroscreen Virology Ltd as its first full-time scientist, he helped spin out the Company from the university and eventually listed it on the London Stock Market as hVivo PLC. Which recently merged with Open Orphan PLC.
He was and still is an active researcher on pre-clinical and clinical trial projects. In 2001, Dr. Rob Lambkin-Williams designed and implemented the first Human Viral Challenge Study to be conducted in Europe in the 21st century He was a company director including being CEO during the growth of the Company, then moving to become the CSO as the number of employees exceeded 300.
He now consults on both pre-clinical and clinical projects on a scientific basis. He has sat on several scientific boards. Having been an active board member as well as an active researcher, he is keen to continue in a business role and is now considering NED positions particularly with university spin-outs, small start-ups, biotechs, NGOs or charities etc.
Caroline’s company works with established companies, challenger brands and start ups internationally with associates based across multiple geographies with diverse in industry and external cross sector experience.
Quality Assurance and regulatory writing.
Sarah has extensive experience with CHIM studies.. Sarah understands that guidelines need to be interpreted and related to the circumstance of the study.
As a result, multiple studies were completed successfully, and these studies have been peer-reviewed and published in high impact journals, e.g., the NEJM
Previously she gained experience in writing regulatory and guidance documents at AstraZeneca including a fit for purpose quality standard for research. During this time,she also co-authoredResearch Quality Association (RQA) publications which are guidance for industry as well as presented at RQA conferences.
She is a Fellow of RQA and has co-authored industry guidance documents.
Expert statistician with experience of CHIM models.
Michael Ghebre has a PhD in Statistics and over 10 years’ experience working as a statistician in industries and academia, including infectious and respiratory disease studies.
Dr Ghebre has extensive clinical trials’ designing experience (vaccine and treatments for influenza, RSV and HRV studies). He has strong statistical and problem-solving skills, such as applying missing data imputation, meta-analysis, modelling structured data, and implementing new Bayesian adaptive approaches in novel study designs. He has published various publications in high impact journals.
is work conducted with clinicians, scientists and other experts, has given him a unique understanding of the complex research/clinical problems that CHIM studies can address and identify statistical models to find the most efficient solution”
Sam Hamilton, PhD
Global Head Medical and Regulatory Writing and Public Disclosure at Clinipace.com
Dr Sam Hamilton – Past President and Fellow of the European Medical Writers Association (EMWA www.emwa.org) – has 26 years of industry experience authoring clinical trials documents in successful FDA and EMA submissions and journal publications. Sam is Chair of the CORE Reference Project (www.core-reference.org).
Sam has extensive respiratory and infectious disease clinical trials experience, including with the human viral challenge (HVC) model. Sam leads the Clinipace Medical Writing Team, and would be delighted to hear from you directly to discuss your medical writing needs