Data Warehousing in Clinical Research and Development From clinical data to knowledge portals Dr. Dieter Schlapsa,b and Dr. Thilo Schmida Computer Sciences Corporation (CSC)a, Wiesbaden (Germany), and Private University for Health Sciences, Medical Informatics and Technologyb, Innsbruck (Austria) Clinical Data Warehousing is a technological approach that allows clinical research departments to link, merge and reuse the clinical data from previous studies to answer new clinical questions concerning drug efficacy and/or safety. This article presents the reasons why data warehousing is of great interest for pharmaceutical research and development, as well as the technical concepts and functions of data warehouses. A data warehouse scenario is set up to illustrate the benefits that data warehouses may offer to the various stakeholders in clinical research. After this, a specific project approach to create data warehouse solutions is discussed, highlighting the authors’ experiences and lessons learned in data warehousing projects. Knowledge portals may extend the usefulness of data warehouses by relating external data from various resources with internal data warehouse information. Portals also can be used to improve collaboration with internal and external user groups. Summing up, clinical data warehouses will allow the improvement of both clinical trial design and clinical study conduct, potentially significantly. Key words Clinical data management • Clinical data warehousing • Knowledge portals |