The growing complexity of clinical research has been met, in tandem, by an explosion of eClinical tools enabling researchers to manage that complexity. Electronic data capture (EDC) has optimized data management. Clinical trial management, a sprawling undertaking, is reined in by CTMS. Trial master files (TMF) have gone electronic. As a player in the eClinical market, Medrio is, of course, thrilled to see so many trials moving away from paper-based processes. But while these technologies make their targeted trial-related processes more efficient, they can, if they remain siloed and unable to communicate with one another, end up slowing a study as a whole. This is why, at a time when CenterWatch reports that investigative sites use an average of no fewer than 12 electronic systems in their clinical trials, software integration is essential.
Integration: what’s at stake?
At the heart of this threat to clinical trial timelines is the fact that more than one eClinical system may need the same piece of clinical data. Clinical data stored in an EDC, for instance, may be needed in a CTMS. If these systems are unable to integrate with one another, researchers are forced to manually extract the data from one system and enter it into the other. The more eClinical systems a trial uses, the more this is necessary – and the more it’s necessary, the more delays the trial incurs. Considering how many eClinical systems play a role in a typical trial today, one may expect integration capabilities, which create easy access to this data by allowing systems to pass data seamlessly back and forth, to be standard in the eClinical industry. The reality, then, may come as a surprise: a significant portion of the top 20 EDC companies are unable to integrate with other eClinical systems.
Those that are, however, can make a world of difference for their users. The efficiency resulting from integration can be a major boon to study timelines and, ultimately, budgets. Clinical Leader reports on the effectiveness of integrations between EDC and interactive response technologies (IRT), for example, in making clinical trials more efficient and less costly. In this area, in fact, Medrio users have firsthand experience: a case study we published in 2017 focused on a CRO who integrated Medrio’s EDC with an IRT provided by a third party. Without this capability, the CRO concluded that their study startup timeline may have doubled.
Secondary benefits for eClinical platforms
Though integration among eClinical systems creates major efficiencies in clinical research, its benefits are not limited to clinical researchers. In fact, the eClinical systems themselves stand to benefit as well. Some EDC vendors, hoping to build out the capabilities necessary to satisfy any and all of their users’ needs in-house, end up spreading themselves thin. Integration makes it possible to avoid this pitfall. If a particular study calls for highly complex risk-based monitoring (RBM), for example, an EDC can integrate with a platform that specializes in RBM, rather than invest time and resources into building complex RBM functionality natively. This allows them to focus their efforts on improving in their area of expertise – becoming a best-in-class EDC – while still offering access to the level of RBM functionality their users need. And all this can be achieved at little to no cost to researchers or EDC providers – Medrio, for example, offers three APIs, which pave the way for integration, for free.
In an age when a single clinical trial often utilizes such a wide range of eClinical platforms, the ability of those platforms to integrate has never been more important – the very value of investing in eClinical technology may, in fact, depend upon it. Without integration, all of these tools, which exist solely to catalyze and simplify clinical research, may instead end up doing the opposite.