First published in International Clinical Trials, Summer 2025
Authors:
Abhrajeet Roy, PhD, Senior Science Advisor, Suvoda
Chris Deatrick, Principal Software Design Consultant, Design Lead, Suvoda
As clinical trials become increasingly complex and patient-centric, outdated eCOA solutions end up adding friction, not reducing it. Here’s why that matters for your data—and how next-gen solutions are changing the experience.
The goal of clinical trials is to collect data that will inform regulators and developers as they determine the efficacy and safety of new therapies. Ultimately, a successful trial is one that collects robust, usable, and high-quality endpoint data. Electronic Clinical Outcome Assessment (eCOA) software solutions have greatly contributed to trial success, facilitating participant compliance in completing trial questionnaires and assessments while minimizing transcription and input errors between paper and electronic systems. However, as trials become more decentralized, patient-centric, and data-heavy, the limitations of legacy eCOA solutions become increasingly apparent.
Older, legacy eCOA solutions frequently come with build, implementation, and usability issues that derail timelines, exceed budgets, and, most importantly, negatively impact data quality. In contrast, systems that adapt in real time, questionnaire processes that break through global bottlenecks, and patient experiences that feel effortless will keep studies on time, on budget, and deliver reliable insights.
The eCOA issues undermining trials
In many ways, traditional eCOA solutions are confining studies with:
- Rigid, One-Size-Fits-All Designs
Traditional eCOA systems often require teams to adapt protocols to the software, not the other way around. One-size-fits-all eCOA systems lead to system-centric design, rather than patient-centric design. This inflexibility creates friction and slows timelines, especially in the face of increasing protocol complexity or adaptive protocol designs. eCOA should have the flexibility to incorporate everything from simple diaries to complex workflows. How could a one-size-fits-all eCOA encompass all these needs? - Sequential Deployment
Global questionnaire builds are hindered by a lack of modularity, as licensing, translation, and localization occur sequentially rather than in parallel, resulting in fragmented workflows. - Siloed Systems and Processes
Many eCOA solutions operate in isolation from eConsent, Interactive Response Technology (IRT), Patient Payments, and other eClinical systems, causing data silos, forcing manual data entry workflows, and requiring integration and reconciliation. For example, when patient data from questionnaires or daily diaries need to trigger immediate decisions about eligibility, drug supply, dose modification, or visit scheduling, disconnected eCOA systems can cause delays. - A Focus on Technology, Not Patients
Many legacy eCOA systems aren’t built with patient usability in mind. They don’t support bring-your-own-device (BYOD), adaptive scheduling, offline functionality, web backup, or reminders and alerts. Many have unintuitive or unnecessarily complex interfaces that patients must navigate, leading to reduced engagement, lower compliance, and a higher risk of dropout. - Limited Flexibility for Mid-Study Changes
Mid-study updates, like adding a new assessment or modifying logic, are becoming increasingly common as trials grow more complex. This process can be slow, expensive, and error-prone in older eCOA systems. If an eCOA system isn’t available during updates, it may lead to data loss or errors if participants must complete paper diaries during the outage. This rigidity delays study progress and increases operational complexity, especially for global trials with diverse regulatory needs. Next-gen eCOA solutions must be able to handle mid-study changes fluidly. - Poor Data Quality, Compliance, and Safety Monitoring
Without real-time analytics or adaptive triggers, most eCOA solutions can’t help study teams proactively monitor deviations, compliance, or patient safety. Ideally, when eCOA data are shared in real-time, sites can respond quickly to noncompliance, update dosing as needed, or schedule additional wellness checks.
Traditional eCOA hasn’t fulfilled its potential in delivery and execution, undermining sponsor trust and holding trials back. But modern eCOA solutions hold great promise for breaking through the bottlenecks of the past.
Next-Gen eCOAs are powerful solutions
eCOA vendors are learning and adapting. Execution is no longer an afterthought, but a core tenet when delivering next-gen eCOA with modular, protocol-driven workflows, interoperable data streams, and real-time analytics that solve traditional eCOA problems:
- Protocol-Driven Flexibility
Modern eCOA solutions are built to adapt to the protocol, unlike legacy eCOA systems. Modular architecture allows study teams to tailor workflows to specific endpoints, populations, and therapeutic areas, while dynamic logic, branching workflows, and configurable assessments create a system that flexes with the trial, not against it. For example, eCOA teams can create dynamic questionnaire scheduling logic that hinges on patient data captured by other eClinical systems (e.g., IRT, EDC). This allows the eCOA system to adapt to live data, only presenting pertinent assessments to the right audience at the right time. - Faster Study Startup
Protocol-driven configuration enables teams to design assessments and workflows that align precisely with endpoints from day one, no retrofitting required. Additionally, a modular questionnaire repository with reusable, pre-validated components reduces design and build time. Rapid build and testing cycles help sponsors launch faster without sacrificing quality or compliance. - Parallel Questionnaire Workflows
By allowing components to be reused, versioned, and updated independently, newer eCOA solutions enable parallel processing of translation, licensing, and localization steps. Design isn’t held up by translations, translations aren’t holding up layout, and layout remains optimized even when new languages are added. - Unified Platforms
Deep integration with other systems like IRT, eConsent, and Patient Payments reduces data silos, eliminates redundant tasks, and creates a common data layer designed for real-time adjustments. For example, an IRT system can interpret live data received from eCOA during an on-site visit and immediately adjust the dose level accordingly. It can also process various inclusion and exclusion criteria captured in eCOA data during screening to automatically gate enrollment and prevent ineligible individuals from completing any further assessments. Additionally, eCOA can trigger automatic patient payments upon questionnaire completion, helping to improve patient engagement. - Intuitive Design
Next-gen systems prioritize ease of use through intuitive user interfaces, patient-tested flows, support for personal devices (BYOD), and designs inspired by behavioral science. They include patient-centric enhancements like reminders, offline functionality, and localization for global usability. This approach drives engagement and reduces dropout rates, particularly for harder-to-reach or rare disease populations. - Modular Editing Capabilities
The newest eCOA solutions support mid-study changes without full rebuilds, enabling teams to quickly add an assessment based on a protocol change or add a new language to an existing assessment when new sites are added, reducing the need for revalidation. Some systems even enable low-code/no-code adjustments, democratizing the ability to implement changes across global teams. - Real-Time Visibility
By embedding real-time reporting into the workflow, modern eCOA also allows for faster course correction. Proactively flagging deviations in compliance, data integrity, or patient safety and engagement helps teams stay ahead of issues. For example, sites can be notified when a patient hasn’t completed a daily diary in the last 72 hours and follow up with reminder notifications. eCOA solutions can also notify the site when a patient reports a concerning response to a mental or physical safety assessment.
By emphasizing transparency, process consistency, and follow-through, next-gen eCOA solutions are rebuilding trust and setting trials up for success.
Next-gen eCOA solutions deliver high-quality data
If complete, consistent, and quality data are like a beautiful symphony, then modern eCOA solutions are the digital conductors. They coordinate every instrument — patients, sites, and sponsors — in perfect time, adjusting tempo and cues in the moment. Not a single sound is missing, misaligned, or out of place, resulting in perfect harmony: clean, timely data that are ready for analysis.
- More Relevant, Complete Data
Tailored workflows only collect necessary data and improve endpoint alignment, reducing noise and minimizing protocol deviations so data are more usable for analysis and submission. - Faster, Cleaner Data
Parallel processing reduces build errors, rework, and delays that can compromise data timelines or completeness, while integration and real-time syncing eliminate manual reconciliation to protect data consistency and accuracy. - Higher Compliance and Fewer Gaps
Easy-to-use and intuitive interfaces, reminders, and other functional features increase participant compliance, leading to more complete and timely data entry. BYOD and offline functionality remove logistical barriers, enabling participation from more diverse populations. Passive data capture can supplement active input and reduce recall bias, while incorporating behavioral science-based elements like gamification can facilitate engagement. - Consistency Despite Change
Efficient mid-study updates mean data collection tools can evolve with the protocol without disrupting ongoing capture, while low-code/no-code edits reduce dependency on lengthy rebuilds. This keeps the system validated and compliant while maintaining data continuity. - Early Issue Detection and Resolution
Live dashboards, triggers, and alerts allow teams to monitor compliance, deviations, patient safety, and data trends as they emerge, not weeks later. This ongoing oversight preserves data integrity by catching and correcting issues before they escalate.
It's time to empower sponsors, CROs, sites, and patients with next-gen eCOA solutions
Next-gen eCOA solutions aren’t just upgrades, they’re essential tools for delivering complete, consistent, and high-quality data without compromising speed, flexibility, or the patient experience.
By eliminating outdated processes and centering solutions around protocols and the patient, next-gen eCOA solutions can help generate data that will rapidly move science and medicine forward.
Author bios
Abhrajeet Roy, PhD, Senior Science Advisor, Suvoda
Abhrajeet Roy began his foray into human behavior research as a bioengineering undergraduate at the University of Pennsylvania and earned his PhD in biomedical engineering at the University of Minnesota. After applying neuroimaging to explore visual perception in graduate school, he continued post-doctoral research in neuropsychiatry, directly engaging with clinicians, sites, and patients on cutting-edge interventions for mental health. Since making the jump to industry, Abhrajeet has shifted his focus to patient engagement and eCOA, leveraging his expertise as a behavioral scientist to both understand and optimize the patient experience in clinical trials.
Chris Deatrick, Principal Software Design Consultant, Design Lead, Suvoda
Chris Deatrick is the Principal Software Design Consultant and Design Lead for Suvoda, specializing in creating unique solutions for pharmaceutical clients across a suite of eClinical SaaS platforms. His expertise includes IRT (IWRS/IxRS), eCOA, and eConsent systems, helping sponsors manage operational challenges with obtaining participant consent, assigning treatment, optimizing the IP supply chain, and accurately capturing participant-reported data. Chris is best known for his excellent client management, problem solving skills, and ability to deliver innovative, user-focused design solutions. He has a B.S. in mechanical engineering from Villanova University.