eCOA

Castor's eCOA / ePRO (Electronic Clinical Outcome Assessments / Electronic Patient-Reported Outcomes) solution is a rapid, compliant, and scalable platform for capturing patient-reported data across traditional, hybrid, and fully decentralized clinical trials. Designed for sponsors and CROs, it is available as a standalone solution or as a natively integrated component of Castor's unified platform, combining EDC, eConsent, and eCOA capabilities under a single login, single database, and single audit trail.

With a global footprint spanning 160+ countries across Africa, Asia-Pacific, Australia, the United States, Canada, Latin America, and Europe, Castor eCOA / ePRO is built to support studies of any scale—from early-phase proof-of-concept trials to multinational pivotal studies. The platform is ISO 27001-certified and maintains full compliance with GDPR, HIPAA, 21 CFR Part 11, ICH-GCP, and applicable regional data privacy frameworks in APAC, LATAM, and EMEA, including support for data localization where required.

Therapeutic Area Experience

• Central Nervous System: Pain, addiction, depression, and broader mental health indications
• Rare Disease: Genetically targeted and low-population studies
• Oncology: Complex, longitudinal studies with high eCOA volumes
• Infectious Disease: Acute and chronic infectious disease, including global surveillance and intervention trials
• Cardiovascular and Metabolic: Hypertension, diabetes, and lipid disorders
• Immunology and Autoimmune: Rheumatoid arthritis, IBD, Crohn's disease, and related inflammatory diseases

Core Technology Capabilities

• API-First Architecture: Seamlessly integrates with EDC, IRT/RTSM, recruitment tools, analytics platforms, and patient payment systems
• No Data Silos: All eCOA data flows in real-time into Castor's unified data layer or any preferred external system
• BYOD Applications: Both web and native mobile apps with multilingual support, accessibility features, push notifications, and delivery via SMS, WhatsApp, and email
• DCT-Ready: Supports in-home, onsite, and hybrid workflows with offline capability and BYOD support
• Standalone or Integrated Deployment: Deploy eCOA independently or alongside eConsent, eClinRO, and eObsRO within a coordinated participant experience
• Library of Validated Assessments: Access reusable, pre-approved PRO instruments including EQ5D-5L, SF-36, EORTC, FACIT, SNOT, PHQ-9, and more to accelerate study builds
• Monitoring and Alerts: Automated system and data monitoring with configurable alerts for study teams and Castor support to preempt potential disruptions
• Global Help Desk: Dedicated multilingual support team with 24/7 availability via chat, email, and phone, backed by SLA-driven resolution times

Unified Platform Design

• Castor eCOA / ePRO is natively integrated with Castor's EDC and eConsent modules—not a separate add-on
• All participant data flows seamlessly into a single system in real-time, eliminating third-party syncs, manual uploads, and fragmented data
• One login, one database, and one audit trail across all clinical data capture modules

Proven Performance and Results

• 1,000+ patients supported in a single study with greater than 95% compliance rate
• 25,000+ ePROs completed using intelligent delivery via SMS and email to keep participants engaged
• Studies deployed in 3–12 weeks from kick-off to UAT using reusable templates and low/no-code tools
• 80% of mid-study changes implemented in less than 4 weeks without disrupting ongoing data capture or introducing compliance risk
• Full compliance with 21 CFR Part 11, ICH-GCP, GDPR, HIPAA, and applicable regional frameworks

Key Benefits for Sponsors and CROs

• Simplify patient engagement across diverse populations and geographies
• Reduce site burden through automated workflows and centralized data management
• Maintain inspection-readiness with a complete, unified audit trail
• Centralize the data ecosystem by eliminating fragmented third-party integrations
• Launch faster with lower total cost of ownership through rapid deployment and reusable study components

Castor eCOA / ePRO is suitable for any protocol complexity, from single-country Phase I dose escalation studies to global decentralized trials spanning 10 or more regions. The platform's compliance documentation covers 21 CFR Part 11, GDPR, HIPAA, and ISO standards, and Castor's expert services team provides end-to-end support to ensure studies remain on track from first patient in to last ePRO submitted.