Clinical Trials

Suvoda eCOA earns High Marks in Patient Usability Study

RWS Life Sciences certification validates that Suvoda eCOA is intuitive and easy to use

Suvoda LLC, a leading global clinical trial technology company specializing in complex studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease, has successfully conducted usability testing of its electronic clinical outcomes assessment (eCOA) solution in collaboration with RWS Life Sciences. The study resulted in the certification of Suvoda eCOA as highly usable and effective for the patient population.

Suvoda announced the general availability of its eCOA product in May 2023 to address the difficulties and delays associated with traditional eCOA products. Suvoda’s solution delivers simplified questionnaire licensing and localizations, as well as streamlined device logistics. And, because Suvoda eCOA, IRT, and eConsent are delivered on a single platform, study teams benefit from improved data integrity.

The findings from the RWS Life Sciences usability testing effort will be presented in a paper titled “Solidifying Usability Testing Guidelines for eCOAs from the Patient Perspective” at ISPOR Europe 2023, to be held in Copenhagen, Denmark, November 12-15.

“Patient-centered usability testing is valuable because it focuses on whether patients can interact with the eCOA efficiently and effectively, particularly in cases where participants may experience physical or visual accessibility challenges,” said Chryso Hadjidemetriou, PhD, with RWS Life Sciences. “The qualitative and patient-centered process of usability testing helps to measure operational efficacy of the eCOA system; recognize design issues causing patient dissatisfaction and impeding data collection; examine software and working improvements; and understand and evaluate user interaction, with an end-goal of improving the users’ experience. This is meant to be an objective means of eliciting the patient experience with an eCOA on a user interface system. With this certification, sponsors can feel confident that Suvoda eCOA is easy to use for study participants while ensuring the integrity of the data captured.”

Nearly all participants in the focus group found Suvoda eCOA to be easy to navigate, intuitive, clear, and well-designed. They appreciated the ease of moving through the questionnaire screens, clear instructions, and the flexibility to change answers as needed.

“Patient-reported outcome (PRO) data is crucial in clinical studies, so it’s imperative to have data capture tools that are easy for patients to use and manage, with minimal intervention from clinical sites,” said Catherine Munera, vice president of biometrics for Cara Therapeutics. “Suvoda eCOA was incredibly easy for our patients to use; we had an increase in patient compliance in completing PRO questionnaires, as compared to previous studies with other eCOA providers. We look forward to bringing this improved eCOA experience with Suvoda to future Cara studies.”

The usability testing process was conducted in accordance with current industry standards and FDA guidance to ensure the highest level of quality and compliance. The focus group consisted of oncology patients using smartphone and tablet devices. These patients represented a variety of conditions related to their cancer diagnoses, including difficulties with gripping and reading, as well as concentration and tactile challenges. The study, which included participants ranging from ages 18 to 75, was qualitative in nature and adhered to best practices in user experience research.

“Suvoda put the user experience at the center of product development so sites can focus time on patients and not on technology,” said Andrés Escallón, vice president, Suvoda eCOA practice. “This study validates that our eCOA solution makes it easy and efficient to obtain quality patient outcomes data for submissions and approvals.”

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