Decades ago, data from clinical trials could only be captured using paper Case Report Forms (CRFs). Researchers would fill out the CRFs by hand at the site of the clinical trial and then pack them in a box and mail them to the trial’s sponsor.
Today, modern medical device companies use electronic data capture (EDC) systems for their clinical trials. Web-based EDC software allows researchers to collect, store, and manage clinical data remotely—no shipping labels required.
But EDC software has come a long way since the first clinical data was sent electronically. Today’s customizable electronic case report forms (eCRFs) and user-friendly EDC systems are a far cry from their predecessors.
So, let’s take a look at where EDC software came from, what it’s capable of now, and how you can use it to capture and manage your clinical data.
The 1980s saw the first step forward—and away from paper—in the use of remote data entry (RDE).
Instead of entering data on paper forms and mailing them to the sponsor, using RDE allowed clinical investigators to record clinical data at the investigation site and send it electronically to the trial’s sponsor.
RDE had a few advantages over a purely paper system:
But remote data entry had its shortcomings, too—the most glaring of which was the hardware requirement. Data could only be sent from a specific computer at the investigation site that was equipped with the necessary software. Installation and user support was expensive, and medical professionals were often frustrated with the poor user experience of RDE, which hindered its adoption.
It wasn’t until the late 90s—and the advent of faster internet speeds—that electronic data capture in clinical trials emerged in a recognizable form. At that point, web-based solutions became more feasible and EDC systems began to take shape.
For the most part, however, electronic data capture was used in pharma trials. Early EDC software worked for these standardized, large-scale trials, but it was difficult to use for the smaller, often unique clinical investigations of medical devices. And for years, the inflexible nature of EDC systems made them all but unusable for the MedTech industry.
The difference between those early, pharma-focused EDC systems and modern EDC software is enormous. Purpose-built EDC systems, like SMART-TRIAL by Greenlight Guru, offer a number of features that better align them with the needs of MedTech companies. For example:
As you can see, electronic data capture has come a long way. Gone are the days of clunky RDE and frustrating, pharma-specific EDC software. Today’s MedTech-specific EDC systems put a premium on usability, flexibility, and compliance.
SMART-TRIAL by Greenlight Guru’s EDC software is the first and only data collection and management solution that’s purpose-built for medical devices and diagnostics.
With SMART-TRIAL by Greenlight Guru, you can design highly customizable eCRFs, then deploy those eCRFs in clinical studies to replace paper-based data collection, eliminate the risk of transcription errors, and reduce the cost of running your study.
Wherever you are in your medical device’s lifecycle, SMART-TRIAL by Greenlight Guru supports you in your clinical activities. Whether you’re gathering data in clinical studies, performance studies, PMCF/PMPF studies, surveys, registries, cohorts, or case series, our solution allows you to collect and manage it all with ease. Even better, it comes fully validated out of the box per ISO 14155.
Ready to learn more? Contact us today for a customized demo.