- Why Us
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:
Entering the data at the site cut down the number of times it needed to be manually copied, meaning fewer opportunities for error.
Clinical data could be sent on a recurring basis, such as every night. Without the lag of shipping time, sponsors could get their data faster.
Better access to data meant errors could be caught faster and trends in patient data spotted earlier. It also allowed sponsors to follow their trials more closely than when they had to wait weeks for boxes of forms to show up at their door.
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 electronic data capture 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 Greenlight Guru Clinical, offer a number of features that better align them with the needs of MedTech companies. For example:
Users can build their own studies. One-size-fits-all doesn’t work for MedTech. There are simply too many types of medical devices, and study protocols can vary widely. Older EDC systems forced MedTech companies to design study protocols that fit their capabilities. Modern EDC systems, however, are designed to accommodate complex device study workflows. Repeated uses or treatments, multi-protocol support, or adverse event (AE) and deficiency reporting are all supported.
Compliance is built in. Regulatory bodies in both the US and EU expect clinical investigations of medical devices to be carried out in accordance with ISO 14155:2020 - Clinical investigation of medical devices for human subjects - Good clinical practice. Many modern EDC systems built for MedTech will be validated out-of-the-box per ISO 14155. They may also include customizable regulatory compliance templates, like ISO 14155:2020 and EU MDR-compliant AE reporting.
Data collection is streamlined. eCRFs aren’t the only source of data that needs to be collected in medical device clinical trials. Electronic patient reported outcomes (ePROs), surveys, and ad-hoc data can all be captured by today’s EDC software. And streamlined data collection results in fewer data entry errors and an easier time fixing mistakes or discrepancies before they influence the outcome of a study.
Data access is immediate. Modern EDC systems allow authorized users to access clinical data as soon as it’s entered into the system. This means researchers can begin analyzing data from eCRFs the moment they enter the system, helping clinical trial managers to see trends earlier and get near real-time access to clinical data. Immediate access can also significantly reduce the timelines and cost of clinical trials.
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.
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 Greenlight Guru Clinical, 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, Greenlight Guru Clinical 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.
Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of Greenlight Guru Clinical (formerly SMART-TRIAL). Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices.