Articles
The CTMS Story: Focusing on Need
By Timothy Pratt, PhD
Originally published in Applied Clinical Trials, March 2006
Problem Posing Needs
How does this relate to a CTMS? Let's start with what is actually needed from a CTMS. Basically, visibility into operational metrics and strategic management of clinical trials, with the goal of getting studies up and running quickly and smoothly and increasing the likelihood of success. The components that make up those broad topics of metrics and management include: site documentation, recruitment rates, overall data quality, IRB status and renewal, clinical product distribution and tracking, resource allocation and utilization, budgets and payments, visit and outcomes monitoring, and more.
These are laudable goals. But standalone CTMS products suffer greatly for the fact that they are inherently overlays onto a variety of disparate systems. That means that someone from your clinical staff has to take time to enter summary information into the CTMS, which necessarily takes time away from their core function of running the study.2 Some systems can draw data from the underlying programs, but as one large pharma company discovered, making that work effectively is a lengthy, time-consuming, and at best ROI-neutral process.3
It has historically been problematic to get software to "talk" to other software. And the simple act of changing the version of one of the underlying software elements in a CTMS may throw everything into chaos when it no longer communicates. The solution to that problem is to stick with the original version of the underlying element, which may condemn large segments of the organization to use obsolescent, bug-ridden early versions for which support may no longer be available. Technology integration or lack thereof is thus a major problem.
Some industry analysts predict that an inability to exchange data with underlying applications will actually cause some established CTMS market players to fail in the relatively near term.4 So, if we concede that standalone CTMS products are not without their problems, what to do? The future, available now from a few leading companies, is actually very bright indeed if we focus on the 1/2-inch hole (AKA the need). And it comes in the form of liquid soap.
