Steffen König has more than 28 years of experience in clinical research. After 4 years in the R&D department of Boehringer Mannheim, he joined IST GmbH where he was instrumental in building the CRO. In addition to knowledge of medical writing, monitoring and project management, he acquired expertise in the fields of pharmacovigilance and data management. The creation of databases and programming of validations and evaluations with SAS enabled him to develop both a data management and a biometrics department. Since the beginning of his involvement with IST, he has been responsible for the development and maintenance of the quality management system. He developed a proprietary project management system to manage project data, budgets and timelines. In addition, he developed a training- and document management system for the administration of project-related training and documents. Since 2009, he has been overseeing quality risk management and has developed a database-driven QRM system with integration of an audit/deviation/CAPA database. Since 1999 he has been a member of the German Society for Good Research Practice (DGGF e.V.) and is the current elected president of the society since 2010. He is the founder of the pharmacovigilance and quality risk management working groups of the DGGF.