To harness increasing amounts of clinical trial data, the biopharmaceutical industry is adopting a burgeoning array of information technologies, from social media to mobile devices and wearable sensors. Together, they are driving novel trial designs—collecting data remotely, reducing patient burden, and bridging controlled clinical trials and real-world therapeutic evaluation.

RBQM will inform how we operationalize trial delivery through core staff competencies and how we collaborate across a broad community of intermediaries and stakeholders. Sponsors and CROs must prepare now for this seismic shift— in how to think about and prioritize risk, and in how to design and conduct clinical studies.