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ePRO/eCOA

Patient-reported and clinician-observed outcome capture for clinical trials, with adaptive workflows, real-time data validation, and 90%+ compliance across oncology, CNS, and metabolic studies.

Solution by Datacubed Health
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Overview

Datacubed's ePRO/eCOA solution is a fully adaptive clinical data capture platform designed for sponsors, sites, and participants across a wide range of therapeutic areas, including oncology, CNS, respiratory, and metabolic studies. Unlike rigid legacy systems, Datacubed is built around human behavior and real-world workflows, enabling everything from simple patient diaries to complex cycle-based oncology trials — all without custom code or lengthy implementation timelines.

By unifying electronic Patient-Reported Outcomes (ePRO) and electronic Clinical Outcome Assessments (eCOA) into a single adaptive environment, Datacubed allows every stakeholder to interact with the study in ways that feel natural, consistent, and reliable. The platform has demonstrated 90%+ compliance and 85%+ participant retention across studies, reflecting its commitment to data quality and participant engagement.

ePRO Capabilities and Participant Engagement

  • Mobile-first design that feels instantly familiar to participants
  • Built-in engagement engine proven to drive 85%+ retention rates
  • Real-time reminders and progress cues designed to feel supportive rather than intrusive
  • Optional gamification features grounded in behavioral science to boost ongoing engagement
  • Flexible device support, including both BYOD (Bring Your Own Device) and provisioned device models
  • Complex survey logic capable of supporting oncology, CNS, and cycle-based trial designs
  • Real-time data checks that produce cleaner, higher-integrity datasets

eCOA Features and Site Workflow Efficiency

  • Full support for all outcome assessment types: PRO, ClinRO, ObsRO, and PerfO
  • Validated, compliant data capture from the very first entry
  • Compliance with 21 CFR Part 11, HIPAA, and GDPR regulations
  • Audit-ready dashboards tailored to the needs of each stakeholder group
  • Automated workflows that reduce the number of clicks required and help prevent errors
  • Effortless integration with EDC systems and existing site infrastructure
  • Centralized oversight across all sites and patient populations

Stakeholder Benefits and Real-World Outcomes

  • Participants report ease of use and the ability to complete assessments at a comfortable pace
  • Site teams benefit from an intuitive admin panel and streamlined development processes
  • Sponsors gain real-time access to patient responses and analytics, improving operational visibility
  • The platform supports geofencing technology to track medical visits and other location-based events
  • Sponsors highlight flexibility, cost savings, and improved patient engagement as key differentiators versus other eCOA providers
  • The solution has been applied in high-stakes research areas including Alzheimer's disease, frontotemporal dementia, and rare disease studies

Datacubed's ePRO/eCOA platform is part of a broader product suite that includes eConsent, engagement solutions, connected sensors and integrations, and reports and dashboards. The platform is supported by expert consulting, fit-for-purpose architecture, project management, and translation services, making it suitable for global, multi-site clinical trials requiring robust compliance and stakeholder-specific configurability.

Meta

Domain
Clinical Trial Management
Subdomain
Patient-Reported Outcomes (ePRO/eCOA) & Patient Engagement
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
Research ScientistClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11HIPAAGDPR