Over the years, the clinical research industry has developed various methods for accessing crucial time savings. Much has been published, for example, on strategies for enhancing patient recruitment, a process that is notoriously vulnerable to delays. EDC, of course, is another major source of these savings. Range checks, for example, allow users to correct errors immediately; once data is transferred to an EDC from its source documents, it can be accessed much more quickly than it could by sifting through file cabinets full of paper.
But EDC has the potential to create shortcuts and eliminate redundancies through more than just isolated functionalities like range checks. A truly optimal solution has efficiencies built right into the interface. Yes, users can invoke particular time-saving tricks – but a more fundamental efficiency comes from simply navigating a smart interface designed to keep study build simple and keep users in control. It’s this kind of intuitive interface that researchers with particularly strict timelines should look for when selecting an EDC for their studies. Here are some signs that they’ve found it.
Masterform for CRF efficiency
A great deal of efficiency can come simply from eliminating redundancies on case report forms (CRF). Many CRFs are collected each time a subject visits a site, and it’s common for EDC systems to require users to build an entirely new version of the same form at each visit – even when the form is largely composed of static data such as birthdate and gender, which of course don’t change from visit to visit. In addition to needlessly extending the study build timeline, this can complicate the reporting and exporting processes and generally cause largely avoidable headaches for researchers.
Why can’t static data simply be captured a single time when a CRF is initially created, and reused later? Medrio has aimed to provide this efficiency by allowing users to build a single form with all the necessary fields available, and, at each visit, simply deselect the fields that aren’t relevant. The ability to simply modify an existing CRF, rather than create an entirely new one, can simplify and catalyze various aspects of the research process.
More control through a drag-and-drop interface
In today’s fast-paced and competitive clinical research industry, few things are as important as the ability to get studies built and deployed quickly. The best way to achieve this is to create an interface that requires no expertise outside of clinical research to use – even with a layperson’s experience in computer technology, users should be able to build studies easily, quickly, and on their own terms. It’s typical for an EDC to require professional programming, either outsourced or in-house, in order to build studies. Much easier is a simple drag-and-drop paradigm that researchers can use to build forms with nothing more than a screen and a mouse. In Medrio, for instance, fields and variables are stored in a master list, and users simply drag them to the relevant forms and place them where they need to go. This process is used for a range of tasks including query building, form arrangement, and form rules.
This simple approach to study build stands in stark contrast to the norm in EDC. When programming is required in order to build a study, the consequences extend beyond the cost of contracting fees – it can also turn study build into a long and cumbersome process. Before a study can go live, data managers and software vendors have to engage in a lengthy correspondence as numerous study specification drafts, user acceptance tests, and project management reviews are passed back and forth between them for approval. A programming-free drag-and-drop approach keeps this entire process in-house, ultimately enabling data managers to reduce study-build time from months to a matter of days.
Aside from reducing reliance on paper, the primary purpose of EDC is to help researchers keep their timelines in check. Things like programming requirements and redundancy in form building are directly counterproductive to this goal. That’s why one of the most important things an EDC developer can do is to create an interface that eliminates these inefficiencies. A software is only truly optimal if it passes this litmus test.