otus clinical services ltd. and hallam pharma consulting ltd
Shirley Hallam has worked in clinical research and development within the
pharmaceutical industry since 1990 for pharmaceutical companies, Contract
Research Organisations and non-commercial sponsors. She has conducted GCP audits
of phase I-IV clinical trials in most European countries and the USA. She has
experience of investigational site, trial master file, database and clinical
report audits, and preparation for regulatory inspection with the MHRA, EMA and
the FDA. Shirley advises on clinical quality management systems, including
writing and managing Standard Operating Procedures. She is also an experienced
trainer, and is Course Principal for the Research Quality Association Advanced
Audit Skills courses. Shirley holds the Institute of Clinical Research
post-graduate diploma in Clinical Research, and the RQA Certificate of Quality
Management. She is a member of the RQA Global Engagement Team, providing
outreach to external organisations including Trust-based and academic
researchers. In 2016 she completed ISO Lead Auditor training with the British
Standards Institute.
