eCOA+

Medable's eCOA+ is an electronic Clinical Outcome Assessment (eCOA) software solution designed for clinical trial sponsors, CROs, and study teams seeking faster study builds, higher-quality data collection, and an improved experience for both sites and patients. As part of Medable's unified data collection platform, eCOA+ integrates seamlessly with eConsent, telehealth, and sensor capabilities, connecting into existing clinical ecosystems through standardized integrations.

eCOA+ delivers industry-leading speed and quality in evidence generation, offering a library of 400+ pre-built and validated instruments, support for 120+ languages, and availability across 70+ countries. The platform is purpose-built to take eCOA off the critical path of study start-up, enabling teams to focus on advancing patient care rather than managing configuration and build timelines.

Core Capabilities

• Combines eClinROs, ePROs, ePerfOs, eObsROs, and digital measures to capture both objective and subjective participant data in a standardized, compliant manner
• A reusable instrument library of 400+ pre-validated assessments, instruments, and diaries enables rapid deployment and consistent data collection across studies
• AI-enabled automation reduces delivery timelines by up to 50%, accelerating study start-up and enabling faster capture of novel endpoints
• Real-time data capture supports immediate, clinically meaningful insights and real-time decision making
• Study teams can store instruments, including translations, in a library for rapid reuse in future studies
• Dashboards keep teams informed of all start-up activities throughout the study lifecycle

Device Flexibility and Patient Experience

• Supports both BYOD (Bring Your Own Device) and provisioned devices, accessible via mobile app or web browser, expanding reach to previously inaccessible patient populations
• Consumer-grade UX with notifications, reports, and submission-ready data, vetted by Medable's Patient Caregiver Network (PCN) and clinicians to ensure accessibility
• Designed to fit into participants' everyday lives through intuitive devices, diaries, and sensors, reducing participant burden and increasing retention
• Improves inclusivity and accessibility across diverse geographic locations and therapeutic areas
• Cross-platform TeleVisit functionality enables seamless site and patient engagement within a single platform, reducing burden and improving compliance

Digital Measures and Sensor Integration

• Standardized integrations for sensors capturing digital physiological measures provide value across therapeutic areas including Oncology, Immunology, Cardiovascular, and more
• Combines traditional eCOA instruments with digital biomarker capture for a comprehensive evidence generation approach

Workflow and Site Efficiency

• Intuitive and automated workflows remove manual entry and configuration time for sites and study teams
• Study build times are up to 35x faster compared to traditional approaches
• eCOA planning is recommended during protocol design to ensure instrument licensing, translations, and visit schedules are aligned from the outset
• Reusable instrument library supports standardized, consistent data collection that drives real-time decision making across studies

Support and Compliance

• 24/7 global customer care support for sites, patients, and study teams throughout the trial, ensuring seamless technology adoption, protocol compliance, and user satisfaction
• Fully compliant with FDA, CFR 21 Part 11, HIPAA, and GDPR standards
• Available in 70+ countries and 120+ locales, supporting global trial execution
• Data collected is suitable for use as primary endpoints in pivotal studies

Medable eCOA+ has demonstrated real-world impact, including helping a top-10 pharmaceutical company reduce Phase III diabetes study build timelines from 16–20 weeks down to just 8 weeks — a reduction of more than 50%. The platform's unified architecture, AI-powered automation, and extensive validated instrument library make it a comprehensive solution for modern, decentralized clinical trials across a broad range of therapeutic areas.