The first IRT systems in the 1990s were completely custom coded. Each application was built from scratch and therefore could meet all the sponsor’s needs for a study because it was 100% customized. End-users loved them since they met their study needs, but they took forever to build and were very expensive.
In the early 2000s, the first parameter-driven, web-based systems were introduced. They were less expensive to build and saved time but only if the system fit the sponsor’s needs out of the box.
So, the industry went from 100% customizable (coded) systems to partially configurable systems. Those systems were off-the-shelf, meaning that the end-user needed to take the system as it was and force fit it to their internal processes, or even more disruptive, change their internal processes to fit the technology. These systems were more than likely considered “enterprise” systems and they were so ingrained into the organization there was a very high probability organizations would stay with older systems purely for the change management it would take to free themselves from “the way it’s always been done.
As technology continues to evolve, either driven by regulatory shifts or scientific breakthroughs (just think about all the new technologies that were spurred on by the RBM guidance or the shift toward biologics and immunotherapies), they can no longer be implemented into the fabric of the organization, but rather need to ebb and flow with the needs of clinical trials.
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