Tim Davis, vice president of strategy at Veeva eCOA, had a conversation with Outsourcing Pharma's senior editor, Liza Laws, and sheds light on how the landscape is changing and what this means for study teams, sites, and overall trial efficiency. In this interview, Davis discusses the hurdles of eCOA, innovative solutions streamlining implementation, and the potential for increased flexibility and efficiency within clinical trials.
eCOA has been around for decades. What keeps eCOA from evolving as quickly as other clinical areas, like EDC?
eCOA adoption lags other clinical technologies due to the history of complex implementation. Traditionally, eCOA solutions must be built individually for each study. Unlike EDC, the build involves complex licensing, translations, and user acceptance testing processes. This made implementation difficult and frequently risks First Patient In (FPI) timelines. As a result, rather than increasing uptake, some organizations revert to traditional paper-based COAs – despite the well-documented impact on data quality – for non-pivotal studies due to the perceived ease of implementation.
How have companies managed instrument libraries, and how can that be streamlined?
Companies have been using code libraries to try to remove the need to build eCOA from scratch for each study. These libraries allow developers to copy and paste the instrument code for each translation into the study build but introduce risks. Code can be inadvertently altered, so instruments still require significant validation, and there is no system to track versions or licensing status, which limits any meaningful reduction in build timelines.
Modern libraries offer a no-code interface where each instrument is built once per language or version and stored in a centrally controlled repository. This allows teams to easily access and deploy instruments, translations, and versions and their licensing information across studies. A key advantage is the ability to streamline the author approval process, particularly for translations. Authors still have final approval, but this approach can reduce reviews to a single confirmation for each language, increasing visibility into instrument usage and simplifying deployment.
eCOA is typically manual intensive and requires additional services. Can study teams build and manage eCOA on their own?
Yes, study teams can now build and manage eCOA themselves. eCOA deployment is complex and requires system experts, but today’s pre-configured systems allow teams to handle the process. Beyond implementation, key tasks that once relied heavily on external services - accessing information, making mid-study amendments, and retrieving data - are now more straightforward. Modern platforms offer real-time dashboards, on-demand data extracts, and self-service options for data changes and user setup, empowering teams to make data-driven decisions and implement changes quickly.
Now, it's about flexibility. Sponsors can manage eCOA themselves, work with a CRO partner, or rely on their vendor — either way, the process is faster and easier than before.
What can be done to improve the site experience managing eCOA?
Sponsors can start by designing systems to align with site workflows. They should be easy to navigate and seamlessly integrate with existing processes. Currently, sites typically must switch to a study-specific tablet to complete eClinROs during visits. Enabling eClinRO completion in the eCOA site portal, where they are already managing the patient visit, removes the need to switch between devices mid-visit. Plus, it eliminates the need for sites to organize and store a separate device for every study.
Adopting a bring-your-own-device (BYOD) approach reduces the need to provision devices and staff acting as tech support for simple queries like password resets. Sites should also be able to use their systems whenever possible, such as sending visit invites from their existing calendar app and teleconferencing platform.
Sites shouldn’t have to log in to multiple systems or repeatedly enter the same information. Fully integrated systems, including single sign-on, can automate data transfer and reduce administrative burden for investigators.
What are the barriers to change?
Clinical trials must ensure regulatory compliance, data integrity, and patient safety. This makes changing how things are done challenging since companies do not want to add risk. For eCOA, decisions have traditionally been made at the study level, with teams focused on immediate milestones. This approach makes it more difficult to implement long-term, organization-wide changes.
Companies that take a more strategic approach can drive meaningful change by addressing eCOA at the organizational level. Standardizing eCOA deployment across studies, programs, and therapeutic areas enables a consistent data capture and management approach, resulting in greater efficiency, improved data access, and streamlined study timelines. This shift removes eCOA from the critical path to study milestones while enhancing the overall experience for sites and patients.
