Electronic Patient-Reported Outcomes (ePRO/eCOA)
Capture patient-reported data directly from participants with our validated, multi-device ePRO/eCOA platform. Purpose-built for global clinical trials, our solution maximises data quality, patient engagement, and regulatory compliance through intelligent workflows, real-time monitoring, and seamless integration with your clinical ecosystem.
Capturing the Patient Voice Directly
Our ePRO/eCOA platform enables accurate, real-time capture of patient-reported outcome data directly from trial participants — wherever they are. Designed to support validated instruments across all clinical outcome assessment types (PRO, ClinRO, ObsRO, PerfO), the platform delivers high-fidelity data that meets regulatory expectations from the FDA, EMA, and other global health authorities.
By placing data collection in the hands of patients, clinicians, and observers through intuitive multi-device interfaces, our platform eliminates paper-based inefficiencies, reduces transcription errors, and provides sponsors with real-time visibility into patient compliance and data completeness across all study sites.
Purpose-Built for Clinical Outcome Assessments
Six powerful capabilities designed to maximise data quality, patient engagement, and operational efficiency across your clinical programme.
Validated Instruments
Full support for PRO, ClinRO, ObsRO, and PerfO instrument types with validated electronic versions, licensing management, and linguistically validated translations. Our platform ensures instrument fidelity through migration certification and equivalence testing.
Multi-Device Access
Responsive design optimised for smartphones, tablets, and web browsers enabling patients to complete assessments anytime, anywhere. Native app experience on iOS and Android with adaptive layouts that maintain instrument validation across all screen sizes.
Smart Notifications
Configurable push notifications, SMS reminders, and email alerts with intelligent escalation workflows. Automated reminder schedules adapt to patient behaviour patterns, with site and sponsor escalation alerts when compliance thresholds are not met.
Offline Capability
Full offline data capture with automatic synchronisation when connectivity is restored, ensuring no data loss in any environment. Patients can complete assessments without an internet connection, with timestamped data integrity maintained throughout.
AI-Driven Engagement
Predictive analytics identify at-risk patients before compliance drops, enabling proactive intervention. Customisable dashboards provide real-time adherence tracking, behavioural insights, and personalised engagement strategies to maximise completion rates.
Real-Time Compliance Monitoring
Comprehensive compliance dashboards with real-time completion rates, site-level performance analytics, and retention forecasting. Automated alerts flag underperforming sites and patients, enabling data-driven corrective actions before data quality is compromised.
Designed for Every Role in Your Trial
Our ePRO/eCOA platform delivers targeted value to every stakeholder — from sponsors seeking strategic oversight to site teams managing daily patient interactions.
Sponsors
- Unified data insights across all sites and regions with real-time aggregation dashboards
- Comprehensive compliance oversight with configurable KPIs, thresholds, and automated alerts
- Real-time visibility into patient engagement, completion rates, and data quality metrics
- Regulatory-ready audit trails and 21 CFR Part 11 compliant electronic signatures
- Reduced operational risk through predictive analytics and early warning systems
CROs
- Standardised processes and re-usable templates accelerating study setup across programmes
- Predictive dashboards enabling proactive site management and resource allocation
- Multi-study management with cross-programme analytics and benchmarking capabilities
- Configurable workflows adapting to sponsor-specific requirements without custom development
- Integrated training and certification tracking for site personnel
Site Teams
- Reduced administrative burden through automated workflows and intelligent scheduling
- Real-time monitoring of patient compliance with at-a-glance status dashboards
- Built-in patient communication tools including messaging, reminders, and escalation alerts
- Simplified training with intuitive interfaces and role-based access controls
- Offline-capable assessments ensuring data capture in any clinical environment
Integrated Across Your Clinical Ecosystem
Our ePRO/eCOA platform is not a standalone solution — it is a fully integrated component of the MTK Pharma eClinical suite. Bi-directional data flows ensure that patient-reported outcome data is immediately available across your entire clinical technology ecosystem, eliminating data silos and manual reconciliation.
EDC Integration
Seamless bi-directional data flow with our EDC platform for unified patient data and automated visit-driven assessments.
RTSM Connectivity
Integration with RTSM for treatment-aware assessment scheduling and stratification-driven questionnaire assignment.
CTMS Alignment
Operational data feeds into CTMS for comprehensive site performance tracking, milestone monitoring, and resource planning.
rSDV Support
ePRO source data accessible through rSDV for remote monitoring and source data verification without on-site visits.
Analytics Engine
Patient outcome data flows into eClinical Analytics for cross-platform insights, predictive modelling, and risk-based quality dashboards.
API & Standards
Open REST APIs and CDISC ODM support for integration with third-party systems, external data sources, and sponsor platforms.
Why Choose MTK for ePRO/eCOA
Regulatory Expertise
Deep understanding of FDA PRO Guidance, EMA qualification opinions, and global eCOA requirements ensuring your data withstands regulatory scrutiny at submission.
Unified Platform
ePRO is natively integrated with EDC, RTSM, CTMS, and Analytics — eliminating data silos, reducing reconciliation effort, and delivering a single source of truth.
Rapid Deployment
Configurable, not custom-coded. Study setup in weeks with re-usable instrument libraries, validated templates, and automated provisioning for faster time to first patient.
Dedicated Support
24/7 patient helpdesk, multilingual support, and dedicated eCOA specialists guiding your programme from instrument selection through study close-out and data transfer.
Built for Multi-Site, Multi-Country Trials
Our ePRO/eCOA platform supports the complexity of global clinical programmes with linguistically validated translations, locale-specific formatting, and multi-language instrument delivery. From regulatory compliance across jurisdictions to time zone-aware scheduling and culturally adapted patient interfaces, every aspect is designed for seamless global deployment.
Maximising Data Quality at Every Touchpoint
Every feature of our ePRO/eCOA platform is engineered to maximise the quality and completeness of patient-reported outcome data. From real-time validation rules that prevent data entry errors, to compliance-driven scheduling that ensures timely completion, our platform delivers analysis-ready datasets you can trust.
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Real-Time Validation
Inline validation rules, range checks, and logical consistency checks prevent data errors at the point of entry.
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Window-Based Scheduling
Protocol-defined assessment windows with automated reminders ensure data is captured within valid time frames.
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Complete Audit Trail
21 CFR Part 11 compliant audit trail capturing every interaction, timestamp, and device identifier.
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Authentication & Identity
Secure patient authentication with PIN, biometric, and multi-factor options ensuring data provenance.
See ePRO in Action
Schedule a personalised demonstration to discover how our ePRO/eCOA platform can transform patient data capture, maximise compliance rates, and deliver regulatory-ready outcome data for your clinical programme.