Three factors to make a next-gen eCOA platform work

As clinical trial designs become more complex, the requirements for participation from both a patient and trial site perspective have also evolved. With compliance being a factor for success, sponsors are being pushed to rethink how they manage and capture clinical outcome assessments (COAs). Speed, scale and precision are no longer simply nice to have, they are the foundation of a successful study. 

In today’s clinical environment, next-generation electronic clinical outcome assessment (eCOA) platforms are emerging not only as tools but also as strategic infrastructure for delivering more efficient, patient-centric trials. At their best, eCOA platforms can accelerate trial startup timelines, streamline operations and improve the consistency and accuracy of COA data. 

To bring these benefits forth, sponsors must approach eCOA platforms not only as another technology deployment but as a clinical enablement strategy. With this mindset, success can be tracked by how effectively that platform supports collaboration, automation and ease of use throughout the trial life cycle.

Aligning people, data and systems

There are three core areas that sponsors and clinical research organisations (CROs) should focus on when implementing a next generation eCOA solution. The first is the development of a collaborative architecture.

A high-performing eCOA platform should include a flexible architecture that enables transparent collaboration between sponsors, vendors, site staff and translation providers. Rather than viewing integration as an optional add-on or a technical feature, those who run trials should view this as an operational foundation. These integrations should include standardised application programming interfaces (APIs) and flexible data pathways to enable the push of eCOA data between systems. 

Flexible architecture positions studies to capture holistic patient experiences across diverse global populations. By integrating eCOA data with additional data sources, clinical trials can unlock deeper insights into patient outcomes and correlations between subjective and objective data points. 

Next-generation eCOA platforms not only minimise sponsor burden, but they also introduce tremendous end-to-end workflow efficiencies. Features like eCOA libraries with prebuilt instruments and the ability to autogenerate code and documentation accelerate development without sacrificing quality. Tech-enabled transparency gives sponsors confidence that eCOA requirements have been captured correctly from the start and can simplify localisation workflows. With strengthened collaboration during the eCOA solution development, sponsors and technology partners have more time to focus on proactive delivery and study management instead of reactive issue management.

In global studies, particularly those involving rare diseases or oncology, this kind of design alignment becomes more critical. Trials often span dozens of countries and languages, and protocols may shift in response to interim data or regulatory differences. Platforms that can accommodate mid-study updates without triggering delays offer a quantitative advantage in time and cost savings.

Automation and efficiency: Two sides of the scalability coin

The second core area is platform scalability. Sponsors are tasked with navigating protocol requirements, varying timelines and heightened oversight expectations. To keep pace, automation must be embedded directly into the eCOA platform’s DNA. 

Modern eCOA platforms provide automation that reduces manual processes, which traditionally slow trial operations. This includes automatic scheduling of assessments, compliance alerts and even triggering next-step actions, like dosing or randomisation, based on patient input. 

Efficiency also depends on how easily a platform supports customisation. Agile systems allow trial teams to generate site-specific configurations, adapt instruments based on region or population and implement protocol amendments without starting from scratch. For sponsors, this means the eCOA can be temporarily removed from the trial’s critical path without creating downstream bottlenecks. This is especially critical because 80 per cent of clinical trials fail to finish on time (1), often due to process inefficiencies and operational delays. Automation within eCOA platforms can address these vulnerabilities head-on, replacing manual tasks with intelligent workflows that maintain compliance, reduce error rates and streamline decision making across the trial life cycle.

The usefulness of automation extends even further with monitoring and data reconciliation. Thoughtfully developed eCOA platforms will be equipped with real-time dashboards, audit logs and intelligent data flags to help sponsors identify and address compliance issues before they escalate, such as missed assessments, patient non-engagement or inconsistent data patterns across sites. These capabilities improve data integrity and reduce the operational noise that can slow trials to a crawl.

Simplifying patient and staff experiences

Clinical trial sites and sponsors can have the most advanced eCOA systems on the market, but if they are too cumbersome for the user base, they will fail to meet expectations. Trials depend on two end-user groups — patients and site staff — and the experience for both must be as seamless and intuitive as possible.

From a patient’s perspective, usability is a pivotal factor that drives engagement. Next-generation eCOA platforms must offer intuitive navigation, language flexibility, reminder notifications, offline capabilities and branching logic that guides users through assessments without overwhelming them. These considerations will directly impact completion rates, data quality and retention, all factors that determine the success of a study.

One way that sponsors are prioritising patient engagement is by adopting a BYOD, or “bring your own device,” strategy. This allows patients to complete assessments on smartphones or tablets they are familiar with and already use. The BYOD approach fosters comfort and accessibility and can be especially crucial among populations dealing with mobility challenges or chronic conditions. If a participant does not have a device, a comprehensive eCOA solution will also offer provisioned devices. Both approaches, BYOD and provisioned devices, ensure inclusiveness across demographics. 

From the site staff’s point of view, accessibility is non-negotiable. Intuitive, user-friendly interfaces lead to faster onboarding, fewer IT issues and more time dedicated to patient care. With role-based permissions, dashboards and workflows are accessible to team members and offer data insights needed to inform clinical decisions appropriate for their given role. Other elements that aid adoption include compressed, targeted training modules and responsive support, particularly for busy sites juggling multiple trials and vendors.

According to a Frost and Sullivan report, 25 per cent to 30 per cent of clinical trials (2) already leverage platforms like eCOA for data collection, patient engagement and monitoring. However, this rate is expected to quickly rise as the adoption of digital technologies in clinical research accelerates and sponsors seek to modernise operations and enhance patient centricity. In this landscape, intuitive, flexible eCOA solutions that simplify the user experience are no longer a competitive advantage — they are an operational necessity.

A strategic decision – not a software selection

Implementing a next-gen eCOA platform is no longer about checking off a list of technology requirements; it’s about building a more responsive clinical research ecosystem. As timelines tighten, regulatory scrutiny intensifies, and patient expectations evolve, eCOA platforms play a pivotal role in trial success.

When sponsors prioritise collaborative architecture, operational automation and intuitive design, the foundation is laid for faster startups, better data and more engaged participants. The result isn’t just a more efficient trial, it’s a more human one.

 

References:

• https://www.mckinsey.com/industries/life-sciences/our-insights/accelerating-clinical-trials-to-improve-biopharma-r-and-d-productivity

• http://www.frost.com/wp-content/uploads/2024/02/Merative-Final-Award-Write-up.pdf?utm_source=chatgpt.com