eCOA

Suvoda eCOA is an electronic clinical outcome assessment solution designed for sponsors and CROs running complex clinical trials. It supports both ePRO (electronic patient-reported outcomes) and eClinRO (electronic clinician-reported outcomes) within a single purpose-built system. The platform is built on the same technology foundation as Suvoda's IRT system, enabling eCOA and IRT to operate through a unified interface and shared database. Suvoda reports an average of fewer than 10 data clarification forms per trial, 100% on-time eCOA deployment, and 100% of usability testers finding the system easy to navigate.

Traditional eCOA solutions have been associated with complications in data collection, limited questionnaire reusability, slow setup, and usability challenges. Suvoda eCOA addresses these issues by combining flexible technology architecture with in-house scientific, licensing, localization, and operations expertise. The system is intended to reduce operational burden for site teams, improve patient compliance with questionnaire completion, and produce audit-ready data suitable for regulatory submission.

Questionnaire Implementation and Localization

• A patented tool called Suvoda Questionnaire Design Language expedites questionnaire creation, translation, layout, and deployment, and supports reuse of a single questionnaire across multiple studies.
• Suvoda Questionnaire XD decouples questionnaire management from the system build, allowing localization to begin earlier and enabling mid-study changes when necessary.
• Questionnaire XD simplifies localization and translation implementation through collaborative, electronic, and compliant workflows.
• In-house experts manage questionnaire licensing, translation, and localization; translation vendors work directly within the system to streamline the localization process.
• A repository of translated and validated questionnaires is available for reuse across modalities, devices, and studies.
• Established partnerships with license holders and translation vendors support reusability and validation.
• The system supports BYOD (bring your own device), provisioned device, and hybrid deployment models.
• Patients complete eCOA assessments through the Suvoda patient app, a single app where patients can also schedule visits, submit receipts, receive payments, view travel details, and receive reminders.

Data Integrity and Platform Architecture

• eCOA and IRT operate on a single platform and shared database, enabling information to flow between the two systems without duplicate data entry.
• The unified platform supports clean data transfers to EDC systems.
• Patient eligibility, randomization, stratification, and dose management can be controlled based on questionnaire inputs.
• Mid-study analysis is supported within the platform.
• The system delivers an inspection-ready and submission-friendly archive.
• eCOA setup at the site is initiated through a shared workflow with IRT, using a QR code download for device configuration.
• Data can be collected from connected medical devices such as glucometers.
• Access to ClinRO assessments can be gated based on rater training and certification status.
• Site users can monitor patient compliance in real time.
• Shared application logic across eCOA and IRT supports accurate and complete data collection.

User Interface and Usability

• The interface design is based on the minimalist look and feel and straightforward navigation of Suvoda's IRT system.
• Usability testing conducted by RWS Life Sciences validated that the system is easy to navigate for study participants, observers, and clinicians.
• The design process was centered on the system user, including patients completing assessments at home.
• Initial device setup at the site is managed through a simple, secure QR code download process.

Reporting Capabilities

• Standard and pre-set reports provide real-time visibility into patient data across both eCOA and IRT.
• Reports cover country, site, and patient-level compliance with eCOA requirements.
• Device status reports track activation, battery level, and sync status for in-clinic and at-home eCOA devices.
• Audit reports covering all eCOA data changes are available as standard.
• An ad hoc reporting function, carried over from the IRT system, allows users to build custom analyses on demand.

Expert Team and Services

• Suvoda's eCOA team includes specialists in scientific consulting, licensing and localization, eCOA operations, and specialty sales.
• The team provides guidance on questionnaire strategy, indication-specific solutions, and regulatory requirements.
• In-house licensing and localization functions manage relationships with license holders and translation vendors directly within the system.
• Device management and logistics are handled as part of the eCOA service delivery operations.

Suvoda eCOA is part of a unified clinical trial platform that also includes IRT, a patient app, client services, and integration capabilities for complex trial ecosystems. The platform has been used in over 900 trials, with 75% in oncology, rare disease, and CNS indications, across 65 countries. Suvoda reports a client satisfaction score of 9 out of 10 in its annual survey.