Most pharmaceutical companies are investigating how digital devices can be utilised in clinical trials to improve the data foundation, and potentially assist in securing a faster time to market and improving patient retention. One common challenge stands out: how do you create a setup robust enough to allow you to include the output data as evidence? This article by Rune Bergendorff from NNIT discusses the common challenges faced and, based on network consultations with a group of pharmaceutical companies, it seeks to identify a viable path forward.