Andy Lawton was most recently at Boehringer-Ingelheim for 28 years. At BI Andy was responsible for managing the statistics, data management and programming groups with BIs UK operation. The group has specialized in the management of large scale trials and the implementation of risk based approaches within them. His experience covers over 33 years in clinical trials, but he also has extensive experience in the areas of computing, statistics, Data Management, RDE and system design. Andy was a founding Committee Member of ACDM and aided in the initiation of CDISC with the provision of the business model. Before joining BI, Andy worked as a statistician in the NHS and in computing in a geophysical exploration company.