YPrime eCOA is a cloud-based electronic clinical outcome assessment solution designed to capture patient, clinician, and observer-reported data in clinical trials. It replaces paper-based instruments with digital questionnaires and diaries delivered via provisioned devices or bring-your-own-device models. The system supports regulated study environments with data validation, multilingual configuration, and integration into broader clinical trial workflows.

Key Features

Electronic Patient-Reported Outcomes (ePRO) Digital collection of patient-reported data.

• Electronic diaries and questionnaires
• Scheduled and event-driven assessments
• Configurable question logic

Clinician- and Observer-Reported Outcomes Structured input from healthcare professionals and caregivers.

• eClinRO and eObsRO support
• Role-based data entry
• Standardized instrument deployment

Provisioned Devices & BYOD Support Flexible deployment models for participants.

• Sponsor-provided devices
• Bring-your-own-device compatibility
• Device provisioning and logistics management

Questionnaire Design & Configuration Configurable study-specific instruments.

• Multilingual support
• Version control
• Branching logic and edit checks

Real-Time Data Access Immediate visibility into collected data.

• Dashboard reporting
• Data export capabilities
• Integration with clinical data systems

Compliance & Data Security Designed for regulated clinical research.

• 21 CFR Part 11 support
• Audit trails
• Role-based access control
• Encrypted data transmission

Patient Engagement Tools Supports adherence and completion rates.

• Automated reminders
• Notifications for scheduled assessments
• Time-stamped entries

Benefits

Improved Data Quality Reduces transcription errors and missing data.

• Built-in validation checks
• Structured digital entry

Higher Patient Compliance Encourages consistent participation.

• Reminder systems
• User-friendly interfaces

Operational Efficiency Replaces manual paper workflows.

• Faster data availability
• Reduced monitoring effort

Regulatory Readiness Supports audit and inspection processes.

• Complete audit trails
• Secure electronic records

Global Study Enablement Supports multinational clinical programs.

• Language localization
• Time zone configuration

Flexible Study Deployment Adapts to various therapeutic areas and trial phases.

• Customizable assessments
• Scalable across study sizes