Author: Andrés Escallón, Vice President, eCOA Solutions Strategy at Suvoda
Snapshot:
Electronic Clinical Outcome Assessments (eCOA) are digital tools used to capture patients’ outcomes data throughout a clinical trial. These data may include patient reported outcomes (ePRO), clinician-reported outcomes (eClinRO), observer-reported outcomes (eObsRO), and performance outcomes (ePerfO).
Clinical trials rely on high quality data to answer crucial questions about the patient’s condition and potential benefits or side effects of the treatment. The method used to collect this information can impact the integrity and quality of the data.
Traditionally, paper-based Patient Reported Outcomes (PROs) such as diaries and questionnaires were used to assess the patient’s experience. Paper data collection puts unnecessary burden on the trial staff to enter and reconcile data between paper forms and the electronic system. Moreover, this system is prone to inaccuracies and poor data quality due to retrospective data entry (“parking lot syndrome”), poor adherence to instructions, illogical responses, and incomplete assessments. Additionally, paper-based PROs introduce the risk of human-error by the trial staff when transcribing handwritten data into an electronic system.
Electronic patient-reported outcomes (ePROs) have gained prominence over the past two decades, alleviating paper-based burdens while providing reliable, accurate, and secure data. eCOA is firmly embedded within the clinical trial landscape, with sponsors reporting in 2023 they used eCOA in 53% of their trials over the previous two years and were planning to use eCOA in 64% of trials over the following two years.
Suvoda eCOA is purpose-built for global clinical trials. Our platform supports multilingual questionnaires and localization workflows so sponsors can run complex, multinational studies with confidence in data consistency.
Several data collection methods are used (whether through provisioned or bring-your-own mobile data collection devices) to gather clinician-reported, patient-reported, and observer-reported outcomes. Assessments collected through eCOA include diaries, indication-specific questionnaires, and quality-of-life measures. In performance outcome studies, eCOA may also integrate with external devices such as spirometers, blood glucose meters, and activity monitors to capture objective measurements.
Looking at ePRO specifically, it is a set of tools to collect outcome measures related to a patient’s experiences and health during a clinical trial, encompassing:
It is especially useful in therapeutic areas that focus on understanding patient experiences and health outcomes, such as oncology, dermatology, and gastroenterology. Note that ePRO is not designed to capture laboratory measures like vital signs, bloodwork, or tissue samples.
For patients, eCOA brings the convenience of entering data electronically wherever they are, minimizing recall errors and fostering sustained participation in clinical trials. Reminders for data entry help patients record their data in real-time and can prevent data from being discarded due to inaccuracies. Reminders, alarms, and notifications also help patients to establish a routine around their data entry, which is critical for improving patient compliance.
An early and pivotal eCOA study revealed that electronic patient outcomes reporting achieved 94% patient compliance, compared to the 11% compliance observed with paper-based methods. Since then, on average, studies have reported that using paper tends to achieve approximately 11-30% on-time reporting compliance.
Site and sponsor teams get immediate visibility to patient information and data entry, which enables faster decision-making and interventions when necessary. The real-time data entry also eliminates errors associated with transcribing paper-based data into an electronic system.
eCOA platforms use encrypted channels to transmit patient data to study databases, protecting confidentiality and providing data protection while adhering to regulatory standards. The real-time visibility into outcomes data allows sponsors to respond promptly to data gaps and compliance issues, promoting data accuracy throughout the trial.
Subsequently, the data collected and stored in an eCOA solution can be shared with other eClinical technologies like Interactive Response Technology (IRT) or electronic data capture (EDC) systems—reducing data re-entry. Study teams then have better data integrity and a clean database ready for analysis. The real-time visibility also allows them to proactively monitor trial progress, making sure that the data collected is compliant before submission.
Today’s clinical trials require resilience and demand efficiency, speed, and accuracy. eCOA has the potential to be an important tool for a more streamlined data collection process and reduced stakeholder burden. Like any technology, eCOA will be most effective at improving reporting compliance and data accuracy when the product is designed with the user at the center, with patients, sites, and sponsors providing input into the product design so the technology is usable and intuitive. What’s more, strong processes and purpose-built services surrounding eCOA delivery and maintenance are critical to realize its promise.
Suvoda eCOA provides rapid and efficient implementation, is delivered on a single platform with IRT and eConsent, and seamlessly integrates with other third-party clinical trial technologies. What’s more, rigorous, third-party usability testing demonstrates that patients find Suvoda eCOA to be easy to navigate, intuitive, clear, and well-designed.
Discover how Suvoda eCOA can bring you closer to more efficient, effective, and patient-centered clinical trials.
One of the most impactful ways to improve trial efficiency is through the integration of eCOA with Randomization and Trial Supply Management (RTSM), the system that manages patient randomization, treatment assignment, and investigational drug supply. But integration between two separate vendor systems is rarely seamless. Clinical teams managing eCOA and RTSM from different providers frequently encounter system integration headaches, data reconciliation challenges,, delayed visibility, and the operational overhead of managing two system implementations, two support relationships, and two sets of system specifications.
The better solution is a unified platform where eCOA and RTSM are built to work together from the ground up. Suvoda delivers both on a single platform, eliminating integration complexity entirely. Sponsors get a consolidated view of patient data real time, less reconciliation headaches, and fewer points of failure across the trial lifecycle.
By: Priyanka Sharma, Senior Vice President, Software Engineering, Suvoda
Snapshot:
The clinical trial landscape is rapidly evolving, and technology is playing a pivotal role in shaping how studies are designed, executed, and experienced by patients. As the head of Suvoda’s software engineering teams, I see three trends shaping the future of development in our field: a heightened focus on patient-centered technology, the acceleration of development timelines through AI and natural language processing (NLP), and advanced cybersecurity and disaster recovery. Suvoda is actively investing in each of these areas so that our solutions not only meet current demands but anticipate future needs.
I believe that innovation begins with empathy. Whether they are enrolling in a trial, interacting with a clinical site, or managing their treatment schedule, clinical trial patients are often navigating some of the most difficult periods of their lives. Suvoda’s software team prioritizes innovations that can reduce users’ burden and deliver clarity in these intense moments.
We bring that same mindset to our product design. That’s why we conduct rigorous usability testing—both internally and externally—to check that our tools are intuitive, accessible, and require minimal training. We draw inspiration from the commercial tech world, maintaining consumer-grade UX standards so that our applications are immediately usable, with limited clicks and scrolls. Patients and site staff shouldn’t have to struggle with technology to access and deliver care.
For example, a usability study on our electronic Clinical Outcome Assessment (eCOA) product highlighted how our thoughtful design enables a better experience, even for users who are not tech-savvy. The study included a focus group of oncology patients, ages 18-75, using smartphone and tablet devices. The patients found Suvoda eCOA easy to navigate, intuitive, clear, and well-designed, and it resulted in the certification of Suvoda eCOA as highly usable and effective for the patient population.
As the clinical trial industry looks to shorten timelines and improve efficiency, AI and NLP are playing a growing role. At Suvoda, we’re using these technologies to streamline key aspects of our platform and reduce the time from protocol to implementation.
One exciting initiative is our work on Sofia, an AI-powered assistant that customers can enable in Suvoda Interactive Response Technology (IRT). Sofia reduces what were once multi-screen, multi-click processes to simple conversations. Instead of navigating complex documentation or interfaces, drug supply managers can simply ask a question and receive clear, accurate, and reliable responses that can include graphs and tables.
We’re also exploring how AI can help translate complex trial protocols into IRT configurations with fewer manual steps. This will not only reduce time and effort but also improve accuracy and consistency in system setup—critical in a highly regulated environment.
In today’s world, cyber threats and natural disasters are unfortunately no longer rare events. The consequences of such disruptions in clinical trials can be profound, potentially affecting data integrity, regulatory compliance, and—most importantly—patient safety.
Suvoda’s software is developed with security as a core pillar. We conduct rigorous security testing throughout our development lifecycle, ensuring our systems are resilient against cyberattacks and vulnerabilities. Our commitment doesn’t stop at prevention. We’ve also built robust disaster recovery and business continuity processes, designed to keep trials running without interruption, even in the face of unexpected events.
Our uptime consistently exceeds 99.9%, and our integrations are engineered to be secure—because in clinical trials, reliability is not optional. Trials run around the clock across global time zones, so our systems must be available 24/7. We continuously monitor and optimize performance to meet this demand, for seamless access and uptime across all applications.
Accuracy is paramount—there’s no room for error when a bug could impact patient care or trial outcomes. We employ advanced automation testing methodologies that ensure our solutions perform exactly as designed, every time.
It’s often said in software development that you can only expect two out of three: cost, quality, and speed. At Suvoda, we've found a way to balance all three—delivering high-quality, secure, and user-friendly software within tight timelines and defined budgets. It’s not easy, but it’s made possible by our deep domain expertise, rigorous development practices, and unwavering focus on what matters most: the patient.
As the industry evolves, we will continue to lead by example—building tools that reduce complexity, improve outcomes, and bring calm to patients during the most critical moments in the clinical trial journey.
Andrés Escallón
Vice President, eCOA Solutions Strategy
Suvoda