Andy Lawton has extensive experience in computing, statistics, data management, RDE/RDC, system design, Risk Based Approach in both CSV and clinical trials. He is currently consultant and director of Risk Based Approach Ltd and has worked with a variety of companies and institutions on the implementation of ICH E6 R2, ICH E8, QMS/QbD and Risk Based Monitoring. Previously, Andy held the position of Global Head of Clinical Data Management at Boehringer Ingelheim were he also held positions of increasing responsibility during his 32 years with BI. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publications is the paper with Dr. Alistair Ross on GP Audit - throughout 80's and 90's this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.

Tim was the Director of Clinical Research Informatics for the Hoosier Cancer Research Network for over nine years and retired in 2019. He has been involved in clinical research for more than 20 years. His interests are in the quality of data and the development of methods to efficiently maintain quality data. He has been the Chair of the SCDM Webinar Committee since 2009.

Donna Gugger Is an Associate Director, Data Management at Turning Point Therapeutics. She has over 30+ years’ experience in Clinical Data Management managing teams, overseeing operations and services, driving strategic initiatives, developing process improvements, and delivering high quality data. Donna is an active member of the SCDM Webinar Committee for the past 10 years. Her interests include risk-based strategies, innovative processes, metric reporting and visualizations.