Collaborative Methodology for Risk Based Monitoring of Clinical Trials

Even though a lot the context from a technology/process standpoint has changed over time. The real guts of what we do has essentially been the same for several decades, if you think about clinical data management being about acquiring data initially from sites, running that through a series of central checks to check if its valid and questioning back to the site if it’s not, and finally turning the data package over to someone downstream (like a statistician) to make a decision. That essentially hasn’t changed over several decades and increasingly that process is just not good enough for what we demand of clinical research. Whether it’s the speed we need to make decisions or the initial quality and burden of getting to the quality places on the sites.

“The biggest challenge and opportunity in my current role is to reimagine what clinical data management really is”

In this exclusive interview, Gary Thompson, Senior Director of Data Sciences, Eli Lilly & Co. sat down the Partnerships in Clinical Trials US team to discuss the biggest challenges and opportunities in clinical data management, risk based monitoring and more.