Study Site Efficiency: Find The Right Tech To Boost Collaboration

By Jae Chung, Vice President, Product Management/Strategy

The era of paper-driven clinical trials has given way to investigative sites inundated with technology. Site staff juggle numerous systems and tools for clinical trial operations, trial data, lab results, imaging results, patient diaries, institutional review boards, and more – with many of the tools not communicating with each other.

There is little evidence that separate systems are helping sponsors and CROs collaborate with sites, or improving clinical trial performance: Study startup time, widely considered a leading cause of lengthy cycle times, has stagnated for years, according to research by Tufts Center for the Study of Drug Development.

These performance challenges are a concern for sponsors and CROs. Sites want feedback about their study conduct, and they want it during the trial, when they still have an opportunity to make corrections if they are veering off course. Sites want to know what is expected of them and have transparency to performance metrics beyond patient enrollment targets. They want to know how they compare to other sites on factors such as time from receiving contracts to completion, time from site activation to first patient first visit, number of days to enter data into electronic data capture (EDC), percentage of randomized subjects who complete the study, and number of errors or queries on documents and time needed to correct them.