The paper to digital migration of eCOAs/ePROs has been quite the journey, particularly in light of COVID-19. The rapid shift to decentralized clinical trials required pharma companies and CROs to adapt data capture techniques quickly while remaining compliant with local regulations.
We recently hosted our annual virtual C3 Summit, which included speaker Aaron McCormick from Moderna. For those who weren’t able to attend, we wanted to share some highlights, focusing on this year’s theme of “Shaping the Future of eCOA/ePRO.”
How can we collect accurate patient data for a new, fast-spreading disease through a decentralized clinical trial quickly, effectively, and safely? That was the overarching topic of discussion between Aaron McCormick and Mark Wade, Global Practice Leader at TransPerfect Life Sciences.
McCormick highlighted several key considerations in facilitating accelerated patient data collection, including study design, workflows, technology, and patient safety. Specifically, McCormick cited:
McCormick’s session ended with him touching upon Moderna’s plan for future COVID variants, and how the Phase III US-based COVID-19 clinical trial has paved the way for future ones to ensure vaccine deployment success.
“We [Moderna] are trying to make things as efficient and scalable as possible.”
– Aaron McCormick
Migrating COAs from paper to digital is a complex undertaking. There’s little room for error when it comes to converting legacy content to the digital version.
Adam Schefflan, Global Practice Leader of TransPerfect, explained that even the most minor of changes in verbiage, synonyms, etc., could impact how the patient responds to the question. This could then affect the entirety of data collection.
Schefflan also noted that there are some adaptions necessary when migrating to a digital format (i.e., “Click here” rather than “Circle here”). Regardless of the number of adaptions, it is a tedious and time-consuming process. This tedium is exactly the type of problem GlobalLink XCompare is meant to resolve.
Christina Farah and Anna Burgan from TransPerfect joined the conversation to explain this in detail. By having the technology track changes and allow for edits within the system, XCompare enables shortened turnaround times and reduced errors.
This was further demonstrated through real-world examples of the application’s use for life sciences organizations.
“By introducing this groundbreaking technology, we were able to reduce migration errors caused by the previous manual process by 97%.”
– Christina Farah
The C3 Summit concluded with Mark Wade, who discussed the current landscape of eCOA/ePRO and how it has changed in the past two decades.
He focused on drivers, including COVID-19, that have had an astronomical impact on patients and studies globally. He also gave suggestions on how to ensure a successful implementation for eCOA/ePRO solutions.
As part of this, he provided a checklist for setting yourself up for a successful eCOA/ePRO deployment. Some key items included:
“If you are US-focused, for whatever reason, you’re missing the trick, because more than half of the studies executed today are non-US.”
– Mark Wade
While the road from paper to digital has not been easy, it is clear that eCOA/ePRO is the future for patient data collection.
As life sciences organizations continue to innovate life-saving treatments, and as technology continues to advance, there will undoubtedly continue to be changes in the way we capture patient data. We’d like to give a big thank you to our speakers and those who attended this year’s C3 Summit—we hope to see you all again next year!
If you missed the chance to see the sessions, don’t stress; we’ve got you covered! All sessions can be viewed here.
Interested in learning more about the C3 Summit or looking for more information on our eCOA/ePRO service offerings? Contact us here.