eCOA

YPrime's eCOA (electronic Clinical Outcome Assessment) platform is a purpose-built solution for sponsors and CROs conducting clinical trials that demand accurate, timely, and patient-friendly data collection across regions, languages, and complex protocols. The platform is designed to accelerate study startup, improve data quality, and maintain inspection-ready oversight from first patient in through data lock. With nearly 1,000 studies implemented globally across 100+ countries and 19+ therapeutic areas, YPrime brings over 15 years of eClinical technology and services experience to global clinical research.

YPrime eCOA combines configurable workflows, advanced reporting, and participant-centered design to support global trials without compromising compliance or data integrity. The platform has demonstrated 47% faster study startup times through pre-validated eCOA libraries and built-in validation, making it a trusted partner for studies requiring rapid deployment, mid-study adaptation, and high-quality data capture.

Core Platform Capabilities

• Faster Startup: A pre-validated eCOA platform reduces build, translation, and validation timelines significantly.
• Global Scale: AI-powered eCOA localization supports 250+ languages and 100+ countries, enabling localized experiences for global patient populations.
• Investigator Oversight: Investigators can review and sign off electronically, ensuring traceable, audit-ready compliance.
• Protocol Adaptability: Rapid updates for protocol amendments are supported without rework or disruption to ongoing trials.
• Participant-Centered Design: The eCOA Participant Hub provides structured, in-app guidance and real-time study visibility to drive adherence and reduce dropout.
• Configurable and Scalable: The platform adapts to protocol complexity, regional requirements, and mid-study change without slowing trials down.

eCOA Portal Features

• Effortless Management: Intuitive tools enable quick setup and streamlined participant tracking, optimizing the site user experience.
• Flexible Scheduling: Visit schedules can be easily adapted to support site staff and participants, improving overall trial efficiency.
• Near Real-Time Insights: Comprehensive trial data and dynamic reporting capabilities enable informed decision-making and data-driven optimization of trial outcomes.
• Empowers sponsors and sites to seamlessly manage participant workflows, maintain visit schedules, and obtain full oversight of clinical trial progress.

Reporting and Analytics

• Instant Access: Query millions of records in seconds for near real-time visibility into participant activity, site performance, and data quality.
• Custom Dashboards: Filter reporting by site, subject, visit, form, or timepoint to focus on the most relevant data.
• Compliance Monitoring: Identify risks early through trend analysis and automated alerts to support proactive oversight and faster intervention.
• Audit-Ready Trails: Every entry, update, and correction is fully traceable, supporting inspection-readiness throughout the study lifecycle.

Participant Engagement and Device Support

• Guided Experience: The Participant Hub embeds structured study guidance directly into the eCOA app to improve participant experience, engagement, adherence, and data quality.
• Device Flexibility: Supports both BYOD (bring your own device) and provisioned device strategies.
• Connected Devices: Integrations with wearables, glucometers, and sensors extend data capture capabilities.
• Global Access: Localized experiences are available for diverse global patient populations.

Protocol Complexity and Therapeutic Area Coverage

• Seamless management of diverse device strategies across complex studies.
• Support for complex, long-duration, and high-enrollment studies.
• Full scalability across therapeutic areas, geographies, and study phases.
• Deep experience in CNS, metabolic disease, oncology, and rare indications.

Proven Real-World Deployment

• In a global Phase 3 oncology rescue scenario, YPrime rapidly deployed its eCOA platform across 216 sites, 900 patients, and 34 countries following critical delays caused by protocol amendments.
• The pre-validated platform was ready for immediate deployment and pre-configured to handle complex study changes.
• Therapeutic area specialists provided strategic guidance to ensure seamless implementation.
• Results included rapid global rollout, seamless protocol amendment implementation, and high-quality, consistent data across all regions.

YPrime's eCOA platform is built to support evolving regulatory expectations, new endpoints, connected devices, and global scale without sacrificing data quality or startup speed. The platform is future-ready and designed to keep pace with the changing landscape of clinical research, making it suitable for sponsors seeking certainty across the full study lifecycle.