Clinevo eCOA

Clinevo eCOA is an electronic clinical outcome assessment platform designed to capture outcomes data from patients (ePRO), caregivers (ObsRO), and clinicians (ClinRO). It is built for life sciences organizations running hybrid and decentralized clinical trials, and is compatible with iOS and Android devices, iPads, and laptops. The platform integrates with the Clinevo EDC system, allowing participant data collected through digital questionnaires, diaries, or remote devices to be transferred directly into a centralized data repository without requiring separate standalone solutions.

Clinevo eCOA is designed to meet regulatory requirements including 21 CFR Part 11, Annex 11, GxP, and GDPR, and is used by pharmaceutical, biotech, CRO, and life sciences clients across the USA, UK, Europe, Korea, Japan, China, and India.

Data Capture and Platform Capabilities

• Supports ePRO (patient-reported), ObsRO (observer/caregiver-reported), and ClinRO (clinician-reported) data collection.
• Collects participant data via digital questionnaires, diaries, and remote devices.
• Transfers collected data to the integrated Clinevo EDC system, eliminating the need for multiple standalone tools.
• Compatible with any device running iOS or Android, including iPads and laptops.
• Supports decentralized and hybrid clinical trial models.

Compliance and Regulatory Readiness

• Complies with 21 CFR Part 11, Annex 11, GxP, and GDPR regulations.
• Includes automated compliance checks and robust audit trails.
• Designed to be inspection-ready for current and emerging regulatory requirements.

Participant Engagement and Usability

• Features a simple user interface intended to require little or no training for participants.
• Delivers alerts directly to participants' smartphones to remind them to take medication or complete research tasks, supporting study compliance.

Monitoring, Reporting, and Integrations

• Provides real-time monitoring, dashboards, and reporting capabilities.
• Built on Java technology, enabling integration with medical devices, EHR systems, and EDC systems.
• Part of a broader one-platform clinical trial suite that includes EDC, IWRS, eConsent, CTMS, eTMF, and remote monitoring capabilities.

Support and Infrastructure

• Includes infrastructure, hosting, training, business process support, and 24/7 application support.
• Offered with transparent, optimized pricing.
• Cloud-based deployment reduces the need for on-site infrastructure and manual processes.
• Dedicated support is available for implementation, training, and ongoing operational assistance.