Capturing patient-reported outcomes is a complex process that traditionally relies on paper-based diaries and outdated methods, which can compromise data integrity, increase transcription errors, and raise the risk of non-compliance. Brandy Bridges, group head of systems and standards, shared how Alcon digitized and streamlined this process with a rapid implementation of Veeva eCOA in order to meet aggressive study timelines.
By focusing on a patient-centric approach, Alcon improves data quality, ensures compliance, and has stronger site and patient engagement across global clinical trials.
Implementation strategyIn order to serve patients in the most efficient way possible, Alcon dove head first into their Veeva eCOA implementation, completing roll-out in just 21 days using a risk-based approach. As Bridges noted, “Veeva eCOA was the fastest implementation we’ve had at Alcon.”
Several factors enabled the quick roll-out, including:Following implementation, Alcon leaders turned the focus to user adoption. Teams expressed concerns about running phase three studies with surveys as primary endpoints, how aging populations and patients would navigate the system without smartphones, and whether the technology was reliable across varying geographies.
Alcon adopted a phased approach with transparent communication to alleviate the concerns. Early studies served as proof points, demonstrating Veeva eCOA’s usability and reliability. Soon after, Alcon made Veeva eCOA a mandatory standard for any study involving questionnaires.
By adopting eCOA, Alcon realized that positive patient experiences led to increased adoption among sites, as its simple user interface and proactive support minimized resistance, allowing sites to enjoy reduced data entry and easier compliance monitoring.
We were able to reduce 90+ edit checks across just three or four surveys. That’s time saved on validation, testing, and ongoing data management.” – Brandy Bridges, Group Head, Systems and Standards, AlconUnified study development
A hallmark of Alcon’s approach was assigning one developer to each study across platforms, taking advantage of the unified Veeva Clinical Platform. This enabled study developers to own builds across Veeva EDC, CDB, and eCOA, and the single point of contact improved consistency, quality, and accountability. Additionally, because teams were already familiar with the Veeva Platform, Alcon was able to reduce onboarding time and greatly accelerate study startup times.
Protocol changes, such as survey additions, schedule updates, or language expansions, were significantly easier with Veeva eCOA for several reasons. Most importantly, no data migrations were required, which meant that new surveys could be deployed without impacting existing data. Teams also preferred eCOA post-production changes over EDC equivalents. In addition to amendments, Alcon utilized the Veeva Clinical Platform to aggregate eCOA and EDC data. With this centralized data, their team could track missing surveys and missed assignments, proactively alert sites showing declining compliance, and maintain a 96%+ compliance rate across studies, even with adaptive designs.
Key takeawaysAlcon greatly improved study efficiency and quality by adopting this patient-centric approach to trials.
Moving forward Alcon is focused on finalizing its eCOA standards and documentation updates, enhancing user experience with more flexible scheduling, and exploring user management efficiencies and broader IRB automation.
For more details on Alcon’s journey implementing Veeva’s unified platform, read more here.