Statistics Powering Risk-Based Quality Management

luePoints Co-Founder and Chief Product & Technology Officer François Torche discusses the challenges of collecting clinical trial data with digital or remote tools (eCOA, ePRO, etc.) without putting the quality of that collected data at risk in the below interview.

“When we talk about risk-based quality management and collecting data, there is a trend to say: We have to simplify, we want to remove the complexity of, a clinical trial. The reality is that we’re doing the exact opposite. We are designing umbrella trials. We’re designing studies where you have phase one, phase two, phase three, all together. We’re doing the exact opposite and I think we have to. So, adopting a risk-based approach is not about trying to reduce complexity; it’s about accepting and addressing that increasing complexity by using the right tools.

“Let’s not underestimate the power of statistical tests. Statistical tests compare data from one site with all the other sites, or one patient against all the other patients, or one country against all the other countries, to compute a statistical score that will tell you at what point a site is atypical in the way certain data have been collected,” he continued. “Our vision of RBQM is providing detecting tools that help someone review what has been identified as a potential issue within a clinical trial, within those data points, to further investigate.”

Watch the complete interview below.