16 Aug Why We Need Technology Consolidation In Clinical Trials

By Dan Schell, Clinical Leader

“If you were asked to design the perfect clinical trial process, I don’t think you’d end up with what we have today,” says a data management expert from a Big Pharma that I recently spoke with. “Sure, we’ve evolved from paper trials to a more digitized landscape, but it’s a patchwork of systems, and we’re all trying to knit the data together.”

Figuring out how to interconnect disparate systems and standardize data has always been a primary function of a data manager’s role. But in the past decade, the number of data points that need to be collected for a trial has grown exponentially. New protocol designs that incorporate, for example, ePRO and eCOA systems, are fueling this growth as is the proliferation of exploratory endpoints. Gone are the days when data was collected, entered into a database, cleaned, and then shared at a later point in time.  Now, a plethora of internal stakeholders want access to trial data as soon as it’s generated (or soon thereafter), not only for safety and medical review, but also for determining if a protocol needs amended or adjusted. “Trying to keep up with this volume and pace of change means we [i.e., data managers] need to be constantly evaluating and implementing newer technologies,” the expert says. Read more…