ePRO Solution for Clinical Trials

FDA-compliant electronic patient reported outcomes platform with validated scales.

Modern ePRO solutions digitize patient-reported outcomes, streamline data collection, and enhance quality of care across clinical trials, pharmaceutical research, and healthcare delivery. CareClinic Compass supports validated scales (PHQ-9, GAD-7, PROMIS), regulatory compliance (21 CFR Part 11, HIPAA, GDPR), and seamless integration with EHR/EDC systems.

ePRO platform dashboard showing electronic patient reported outcomes for clinical trials with validated assessment scales, symptom tracking, and data analytics
Validated Scales
Real-Time Data
FDA Compliant

ePRO Platform Advantages

Electronic patient-reported outcomes improve data quality, enhance regulatory compliance, and enable real-time monitoring for clinical trials and healthcare organizations.

Real-Time Data Capture

Eliminate recall bias with immediate symptom reporting. Patient data is captured as events occur, ensuring timestamp integrity and higher data granularity for clinical endpoints.

Regulatory Compliance

FDA, EMA, and MHRA-compliant platform adhering to 21 CFR Part 11, ISO 27001, GDPR, and HIPAA standards. Audit-ready data with time-locking and secure storage built in.

Enhanced Data Quality

Structured data collection with built-in validation rules reduces queries and improves compliance. Real-time alerts flag missing data or concerning patterns before they impact trial integrity.

Multi-Platform Access

BYOD (Bring Your Own Device) support across iOS, Android, and web browsers. No app installation required. Participants access assessments through any device, reducing technical barriers to enrollment.

ePRO Use Cases

From pharmaceutical clinical trials to value-based care programs, ePRO solutions enable comprehensive patient monitoring and outcomes assessment.

Clinical Trials & Pharmaceutical Research

Pharmaceutical sponsors and CROs leverage ePRO platforms for Phase II-IV trials requiring patient-reported endpoints. Validated instruments (PHQ-9, GAD-7, PROMIS, EQ-5D) support regulatory submissions with FDA/EMA-compliant data. Multi-site coordination, remote data monitoring, and automated adverse event flagging streamline operations while maintaining data integrity.

Validated Scales
Multi-Site
Audit Trails

Healthcare Organizations & Value-Based Care

Health systems and clinics adopt ePRO for chronic care management, population health monitoring, and quality improvement initiatives. Track patient outcomes between visits, identify deteriorating patients early, and demonstrate value-based care metrics to payers.

Population Health
Early Alerts
Quality Metrics

Academic Research & Real-World Evidence

Research institutions collect real-world evidence through observational studies, registry databases, and longitudinal cohort tracking. Custom assessment instruments and flexible data schemas support diverse research questions while maintaining scientific rigor.

Custom Forms
Longitudinal Data
Data Export

Decentralized Clinical Trials (DCTs)

The rise of virtual clinical trials demands robust ePRO infrastructure. Remote patient monitoring, multilingual interfaces, offline data capture, and threshold breach auto-flagging enable site-less trial designs while maintaining data quality and participant engagement.

Offline Mode
Multi-Language
Remote Sites

ePRO Platform Features

Advanced features designed specifically for clinical research, pharmaceutical trials, and healthcare organizations requiring validated patient-reported outcomes.

Validated Assessment Instruments

Pre-built validated scales including PHQ-9 (depression), GAD-7 (anxiety), PROMIS (quality of life), pain scales, EQ-5D, and disease-specific assessments. Custom form builder supports proprietary instruments and conditional branching logic.

Comprehensive Symptom Tracking

Patients report symptoms, adverse events, and side effects through structured forms with severity ratings. Body symptom mapper enables precise anatomical localization of pain and symptoms for clinical endpoint assessment.

EHR & EDC Integration

Seamless integration with EHR systems (Epic, Cerner, Allscripts) and EDC platforms (OpenClinica, Medidata Rave) via FHIR APIs. Export data in PDF, CSV, FHIR, or custom formats for analysis and regulatory submissions.

Security & Compliance Infrastructure

21 CFR Part 11 compliant with electronic signatures, audit trails, and data time-locking. HIPAA, GDPR, and ISO 27001 certified infrastructure ensures patient data protection and regulatory readiness for global trials.

Real-Time Alerts & Monitoring

Configurable alert thresholds notify investigators when patients report severe adverse events, suicidal ideation, or concerning symptom patterns. Dashboard provides real-time enrollment status, compliance rates, and data quality metrics.

Analytics & Reporting Tools

Built-in analytics reveal symptom patterns, treatment response correlations, and adverse event trends. Generate regulatory-compliant reports with statistical summaries, visualization charts, and longitudinal patient timelines.

Multi-Site Study Management

Centralized study management dashboard for CROs and sponsors coordinating multiple sites. Role-based access controls, site performance analytics, and real-time enrollment tracking across global trial networks.

Patient Engagement Tools

Automated reminders increase assessment completion rates. Medication tracking, health journaling, and educational content keep participants engaged throughout long-term trials and chronic disease studies.

Implementation Process

1. Study Configuration

Configure study protocols, assessment schedules, and validation rules. Select validated instruments or build custom forms with branching logic. Set up multi-site access permissions and workflow automation.

2. Site Training & Deployment

Train site coordinators and investigators through virtual sessions covering patient enrollment, data monitoring, and adverse event management. White-label deployment under your organization’s branding.

3. Patient Enrollment & Data Collection

Enroll participants via email, SMS, or QR codes. Patients access assessments through mobile app or web browser without complex setup. Real-time monitoring dashboard tracks compliance and data quality throughout the study.

Who Uses ePRO Solutions

From pharmaceutical companies to academic medical centers, diverse organizations leverage ePRO technology for patient monitoring and outcomes research.

Pharmaceutical & Biotech Companies

Clinical development teams use ePRO platforms to collect patient-reported efficacy and safety endpoints for regulatory submissions. FDA/EMA-compliant data supports NDA/BLA applications with validated instruments and audit-ready documentation.

Contract Research Organizations (CROs)

CROs managing multi-site trials benefit from centralized data monitoring, site performance tracking, and automated quality control. White-label deployment allows seamless integration into sponsor-branded trial ecosystems.

Healthcare Systems & Hospitals

Integrated delivery networks deploy ePRO for quality improvement initiatives, value-based care reporting, and patient-centered outcomes research. Population health dashboards identify high-risk patients requiring intervention.

Academic Medical Centers & Research Institutions

Universities and research hospitals conduct investigator-initiated trials, registry studies, and observational cohort research. Flexible data schemas and custom form builders support diverse research methodologies.

Frequently Asked Questions

What is an ePRO platform for clinical trials?+
CareClinic Compass is an electronic patient-reported outcomes platform that enables patients to report symptoms, side effects, and quality-of-life data during clinical trials through mobile apps or web portals. The platform uses validated assessment instruments with real-time data transmission to investigators.
How do I ensure FDA compliance with electronic patient reported outcomes?+
CareClinic Compass adheres to FDA 21 CFR Part 11 requirements with electronic signatures, comprehensive audit trails, and data time-locking. The platform maintains HIPAA, GDPR, and ISO 27001 compliance for global regulatory submissions.
What validated ePRO assessment scales does CareClinic support?+
CareClinic Compass includes PHQ-9 for depression, GAD-7 for anxiety, PROMIS for quality of life, standardized pain scales, and EQ-5D. The custom form builder supports proprietary instruments with branching logic.
Can I integrate ePRO data with my EDC system?+
CareClinic Compass integrates with OpenClinica, Medidata Rave, and Oracle InForm via FHIR APIs. Data exports in CSV, PDF, FHIR, or custom XML formats for seamless eCRF workflows.
How does ePRO software improve clinical trial data quality?+
CareClinic Compass uses built-in validation rules, range checks, and conditional logic to reduce data entry errors. Real-time alerts flag missing assessments, and timestamp verification ensures regulatory-grade data integrity.
Can I use ePRO for decentralized clinical trials?+
CareClinic Compass supports virtual and hybrid trials with offline data capture, multilingual interfaces, and BYOD compatibility across all devices. Participants complete assessments remotely without site visits.
What security standards does the CareClinic ePRO platform meet?+
CareClinic Compass maintains HIPAA, GDPR, and ISO 27001 compliance with 256-bit encryption and role-based access controls. Regular security audits ensure comprehensive patient data protection.
How do I customize ePRO forms for my clinical study?+
CareClinic Compass provides a custom form builder with branching logic, skip patterns, calculated fields, and validation rules. Forms support multiple languages and complex scoring algorithms for research protocols.
How long does ePRO implementation take?+
CareClinic Compass deployment typically requires 2-4 weeks from protocol finalization to enrollment. This includes form building, site training, and integration testing.
What features improve patient engagement in ePRO studies?+
CareClinic Compass uses automated reminders, push notifications, and progress tracking to increase completion rates. Educational content and symptom visualization enhance participant understanding throughout long-term trials.
Can healthcare organizations use ePRO outside clinical trials?+
CareClinic Compass supports chronic disease management, post-surgical monitoring, and value-based care programs. The platform enables real-world evidence collection and patient registry maintenance for quality improvement initiatives.
What reporting capabilities does the ePRO platform include?+
CareClinic Compass generates regulatory-compliant reports with statistical summaries, trend charts, and adverse event timelines. Export options include PDF, Excel, SAS, and SPSS for downstream analysis.

Transform Your Clinical Research with ePRO

Join pharmaceutical companies, CROs, and healthcare organizations using CareClinic Compass for FDA-compliant electronic patient-reported outcomes. Improve data quality, enhance regulatory compliance, and streamline clinical trial operations.