Data management and electronic data capture with clinical trials

Electronic data capture (EDC) was introduced at Bayer more than 15 years ago, initially slowly but recently a decision was made to run all internally managed trials using EDC. For those starting the implementation of EDC it may seem to be of utmost importance to select the appropriate tool for EDC. While this is certainly true to a certain extent, it turned out that the adjustment of processes in monitoring, data management and data cleaning was clearly even more important to successfully implement EDC. The modification of processes facilitated a smooth transition from one to the next EDC system at Bayer, currently rolling out the fourth EDC system in the organization without major interruption of the business. This paper will provide several aspects of the process side that require attention, once an EDC tool has been selected.