Michael Hughes, Senior Director eCOA Operations at YPrime told us the solution is unique in its focus on the user experience as way to boost data integrity.
“We believe our solution significantly improves the sponsor’s experience by providing full management control without relying on their supplier, which includes the ability to see their data, control device inventory, manage users and see trends in real-time,” he said.
Key features of the solution include inventory management, device agnostic syncing, automated DCF processing, and mobile reporting.
It also supports single sign on, ad-hoc analytics, and features an instrument library that gives sponsors the ability to retain information for future studies.
According to Hughes, the build process is now more collaborative with the sponsor team.
“The overall experience of the process from the first meeting through user acceptance testing (UAT) is focused on making it much easier for non-technical study team member to understand how system requirements translate into working software, so there are no surprises and minimal findings,” he said, adding that this approach can also reduce built times.
Additionally, the eCOA platform has a shared architecture with the company’s IRT system, which Hughes said creates greater efficiencies by removing duplicate data entry.
“In practical terms, this means patient identifiers, status and drug assignments that are created in the IRT system can be consumed by the eCOA system without the need to recreate them on a device.”
In developing the eCOA solution, YPrime addressed some of the most common site user “headaches” in building functionality, said Hughes. For example, site users do not have to set up clinical trial patients on a device if they have already enrolled in another system.
“In our eCOA platform, that information is pulled in and preloaded for them, and shared across all devices,” he said.
Device independent syncing capabilities also eliminate the need to assign patients to specific devices.
Hughes said patients benefit from a streamlined design that guides them through their entries. “A range of modalities support the “BYOD” approach,” he added.
The BYOD (Bring Your Own Device) approach has been gaining traction in the industry as the FDA pushes for electronic patient reported outcomes. As outsourcing-Pharma.com previously reported, the approach allows patients to use their own smartphones to compete field-based PRO assessments.