We’re in an age of digital disruption that has touched every corner of our economy, from the hospitality industry to the taxi industry to healthcare and clinical research. In this environment, we often see innovation moving at breakneck pace, with regulators scrambling to catch up. In clinical research, both innovation and regulation are sites of great change. Digital transformation, from eClinical software to remote data capture apps and beyond, is churning along; Europe is preparing for massive new regulatory frameworks that will have a great impact on the way clinical trials are conducted. These changes are occurring more or less simultaneously, raising some important questions: What can researchers, vendors, and regulators do to ensure that these changes occur in sync - that the technology opening new doors in the capture and analysis of clinical data, and the guidance responsible for regulating them, keep up with one another?