With the necessary technology and the support of the FDA in place, the eSource revolution is charging forward. Researchers are marveling at the efficiencies eSource creates as its adoption becomes more widespread. While one may expect that a new, groundbreaking technology will initially be met with some resistance from the industry it affects, eSource has already proved highly effective in reducing paper usage, monitoring, and many other costly and time consuming aspects of the research process. Sponsors have been able to reduce their timelines and budgets through paper-free data capture and near total elimination of source data verification.
But sponsors aren’t the only ones celebrating the eSource revolution; sites have a lot to gain from the technology as well. In addition to saving sponsors time and money, the products in Medrio’s eSource suite create ease and optimize the workflow for site staff. Here’s how.
Eliminating paper from data entry
The fundamental benefit of eSource for sites is the paperless data entry it makes possible. Sites are free of the burden of storing and keeping track of cumbersome amounts of paper CRFs. Beyond space efficiency, site staff have access to the same features in mCapture, Medrio’s eSource-equipped tablet application for clinical data capture, that data managers have come to enjoy and depend on in Medrio’s EDC. There is skip logic to catalyze the data capture process, and range checks to alert site staff to any erroneous data entry. Calculated variables offer protection against human error on the part of the user, and protocol changes sent down from the sponsor are easy to implement at the site level. These features offer sites a level of efficiency in their data entry and confidence in their data security that is virtually impossible with paper-based data capture.
Learning new technology can be daunting, of course, especially when required in connection with one’s job. But for clinical trial sites, Medrio’s eSource doesn’t create burdens; it removes them. mCapture allows site staff to access all subjects and all visits from the same location, and makes it easy to switch from one study to another. It also allows users to enter data offline, rendering the threat of an unreliable internet connection, which can endanger data quality and slow the data entry process, irrelevant.
This kind of convenience extends beyond data entry and navigation: eSource also makes it possible for monitors to view data remotely, significantly reducing the necessity of site visits. As such visits typically entail a great deal of preparation on the part of the site, this amounts to a major alleviation of what can be a stressful process.
Providing regulatory peace of mind
Whenever a game-changing technology arrives in a heavily regulated industry like clinical research, it should come as no surprise when compliance concerns arise. How can sites and other interested parties be sure that a new eClinical tool is aligned with all of the many facets of the regulatory frameworks that govern clinical research?
Any eSource user with this concern should find it reassuring that the FDA fully backs eSource, and has released guidance for its use in clinical trials. And Medrio’s investments in compliance are particularly strong. Medrio’s eSource applications, like all Medrio products, are fully compliant with CFR Part 11. They’re also protected by secure login, audit logs, and form permissions.
It’s difficult to dispute that eSource delivers major time and cost savings to clinical trial sponsors. But the right kind of eSource products can be a source of convenience and comfort for site staff as well. It is this understanding – that the technology can be a boon for all parties involved with the clinical research process – that has earned Medrio a position at the forefront of the eSource revolution.
Interested in Medrio for your clinical trials? Get in touch with our sales team to schedule a demo!