Technology advancements have made it possible to enter electronic source data in real-time during subject visits, ensuring that all data is captured and accurate. By streamlining processes and allowing for remote monitoring, eSource improves compliance for all involved parties. In the past, the only way to check source data was to send monitors to visit the trial site. This was expensive, took a long time, and didn’t happen very often. Using tools like eConsent and eSource, trial sites can now remotely monitor data in real time. This not only reduces the time and money spent on monitoring visits, but it also establishes a real-time feedback process from the sponsors and a clinical research organization like Veristat to the site to fix errors as they occur and build quality into the data at the point of entry.
Using eSource in a clinical trial has many advantages, some of which are listed below.
Easier compliance with sponsor protocols
Every patient visit requires source information, which sometimes has two forms and sometimes 20. Thus, site team members can find it difficult to track all the data. To ensure compliance, source capture is essential. It’s about following protocol and gathering all the sponsor-requested data. And you must do it efficiently and successfully. eSource lets you program the whole protocol, visits, and site user behaviors into an electronic format. This lets site users accurately follow the protocol. Then you know all the patient information you need to capture, can easily capture and log it, and save it safely in a digital system instead of using paper.
Optimized clinical trial workflows
Creating custom source templates and making sure they comply with protocol standards can be a time-consuming process for trial sites. However, having a technology partner develop eSource documents following the study protocol relieves you of the time and effort required to construct source forms on your own. As the virtual clinical trials go on, you can digitally allow principal investigator reviews, signatures, and verification to make the process go more smoothly.
Improved data accuracy
eSource can be customized with preventative features. When making the eSource forms, ranges can be set for certain patient data to avoid mistakes. For instance, if you seek to record your heart rate and include a leading zero, the digital system can notify you that you’ve made a mistake. To fix any previous inaccuracies, simply retype the number.
Data verification and remote monitoring
Remote monitoring, where the research associate virtually verifies all of a site’s source documents, grew during the COVID pandemic lockdowns. eSource lets sites and sponsors work on the same cloud-based platform, so the CRA can simply sign into the system to view electronic documents. If you’re thinking about using eSource, be sure the proper safety measures are in place first. In this instance, your site team should have the ability to control who has access to eSource documents, when they have access, and whether or not they have access at all.
Adopting eSource is now a necessary step for companies to make huge leaps in productivity and speed up the development of life-saving treatments. Those who act quickly can position themselves to gain the most significant result.
