In the past years, companies have increased their focus on the oversight and prevention of potential risks impacting individual clinical studies or the overarching clinical program success by means of subject well-being and protection, data quality and site performance as well as accuracy and correctness of final study results.

This change in perspective has been encouraged by regulatory authorities with both FDA and EMA guidelines released in 2013 for risk-based quality management of clinical investigations and with the release, in 2016, of the integrated addendum to the ICH E6 guideline, specifically addressing the need for a quality management system using a risk-based approach.