Owner, Sue Fitzpatrick Associates
Sue Fitzpatrick has more than 30 years' Pharmaceutical Industry experience. She has been responsible for the management and audit of CRAs, CROs and clinical trials in a wide range of therapeutic areas. As former Director and Head of Education and Training at the Institute of Clinical Research she was responsible for the provision of training courses for the industry and for postgraduate courses in collaboration with several UK Universities. Sue is an accredited teacher with Cranfield University and continues her collaborations but as a consultant trainer. Sue conducts courses in many topics including risk based monitoring (RBM).
Sue is currently a Director of Redtree People and continues her work on enhancing competencies and standards, writing industry gold standards for CRAs in collaboration with COGENT the sector skills council. She was a member of the GCP committee of the Faculty of Pharmaceutical Medicine and helped develop a certification examination for physicians and other research personnel. She is a senior collaborative consultant for NNEdPro Cambridge Hub. She has authored many articles and books on clinical research, risk based/centralized monitoring and career development topics. Sue has recently published a book in Clinical and Healthcare Research with the Oxford University Press.
Risk Management Trainer and consultant, Sue Fitzpatrick Associates
Over the past 30+ years Jane has moved from routine data cleaning activities, via system validation on to training and data quality activities, eventually specializing, within her role as a Quality Risk Manager, in Risk Assessment and Management. Jane's Risk Assessment and Management expertise covered a range of areas from the R&D Management team, through individual departments and then clinical trial teams and process improvement projects, not forgetting software development projects, large and small. Over that period of time Jane has worked for a number of major Pharmaceutical companies and CROs, before retiring from one of the top pharmaceutical companies.
Jane has also been involved as a contributory author to a number of System Validation guidelines â?? Computer Systems Validation, A Practical Guide 1998; Computerized Systems Validation in Clinical Research, A practical guide 2004 and most recently Validation and Management of e-Clinical Systems in Collaborative Clinical Trials 2015.
Jane now operates as a Risk Management Trainer and consultant, specializing in Study Level Risk Management and Risk-based Monitoring as well as facilitation of risk assessment workshops.