Medical monitoring is an essential part of the clinical trial process, primarily to keep study patients safe from any potential harm, and also to maintain the integrity of medical data supporting the trial. The physicians responsible for this oversight have been called the unsung heroes of clinical trial development.1 The challenges they face can be daunting; not only are there far more clinical trials, each trial generates exponentially more data than ever before. Identifying signals during the safety review process has increasingly become like finding a needle in a haystack.
Technology vendors are stepping up to ease the burden, but medical monitors have been slow to adopt solutions. This white paper examines the reasons behind the physician monitors’ reluctance, and what technology needs to offer to convince monitors their work can be more efficient — quickly detecting safety signals and speeding time to submission.