The continuously evolving clinical research industry requires new solutions and renewed approaches. Rising costs, studies getting more and more complex and, what is more important, constant focus on quality and safety of patients, demand devising new methods to conduct clinical trials. At the same time as electronic systems are used more widely, statistical methods and capabilities get more sophisticated and work moves to virtual offices. Anna Wójciuk, Clinical Data Manager at KCR, shares her thoughts on risk-based approaches in clinical trials.