By Masha Hoffey, Director, Clinical Analytics at PerkinElmer, Inc.
Medical Monitors are the unsung heroes of clinical trial development. They face an enormous set of challenges as they work to protect the safety of trial subjects, trying to maintain a view of the “big picture” while tracking adverse events, labs, and vitals for hundreds, sometimes thousands, of individual patients. Medical monitors coordinate with project managers, data managers, biostatisticians while also working directly with sites and investigators, responding to queries, and tracking thousands of rows of disparate data from electronic data capture (EDC) systems or labs vendors. At the end of the day, there is nothing more important than the safety of trial volunteers, and medical monitors are critical to ensuring that focus.
In my strategic product management role at PerkinElmer Informatics, I often talk to medical monitors about the obstacles they face and their impact on the overall study conduct, operational efficiency, and most importantly, subject safety.