When we talk with sponsors, the vast majority of them say that data integration across clinical trial applications—EDC, CTMS, ePRO, IxRS, labs, safety, etc.—is the one thing that would most benefit their teams. Clinical trial data unification is a key springboard for numerous improvements that can help sponsors complete trials in a timely manner, with a better chance at approval.
With the overall clinical trial approval rate in the mid teens, it’s important to note that about half of study rejections are due to controllable factors, such as poor data quality and inferior audit readiness. It’s one thing for a trial to be denied because a drug or device doesn’t work, but quite another when a rejection comes from data issues that could have been prevented. In such cases, the pain of the lost investment, missed revenue potential, and the failure to treat patients is even more acute.