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.