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eCOA

Patient-reported, clinician-reported, and observer-reported outcomes collection for decentralized clinical trials with real-time data capture and multilingual support.

Solution by Jeeva
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Overview

Jeeva's eCOA software is a decentralized clinical outcomes assessment platform designed for clinical trial teams conducting patient-centric, remote, or hybrid studies. It supports the full range of electronic clinical outcome assessment types: Patient-Reported Outcomes (ePRO), Clinician-Reported Outcomes (ClinRO), Observer-Reported Outcomes (ObsRO), Performance Outcomes (PerfO), and eDiaries. The platform is accessible in participants' native languages and operates on a Bring Your Own Device (BYOD) model, allowing patients to report outcomes securely from their own smartphones or tablets.

The platform is built to remove distance and language barriers for clinical trial participants. It integrates with controlled vocabularies such as MedDRA, supports multimedia-enhanced assessments, and delivers real-time data directly from participants to researchers, with the aim of reducing data loss and improving compliance.

Core Platform Capabilities

  • Drag-and-drop form builder supporting a variety of question types
  • Questionnaire scoring based on user-entered values at each instance
  • Branching and skip logic configuration for adaptive survey flows
  • Automatic reminders and notifications sent to non-responders or defined responder groups
  • Data export at any time by authorized users in a ready-to-analyze format
  • Built-in data and form validation to support accurate data capture
  • Compatible with most browsers and devices across screen sizes
  • Customizable recurrence settings, branding, banner images, and authentication options including OTP verification
  • Modular design allowing addition of other features such as eConsent, TeleVisits, and EDC

Data Collection and Participant Engagement

  • Real-time data collection enables researchers to review patient-reported outcomes instantaneously and make rapid protocol modifications in response to amendments
  • Adaptive reminders delivered via SMS, email, and in-app notifications, timed to participants' visit windows and local time zones
  • Offline data capture support: responses are stored on the device and automatically synced to the study database once connectivity is restored
  • Real-time compliance dashboards provide study teams with visibility into data completion rates, response timeliness, and outlier identification
  • Provisioned devices available for participants who do not have their own, in addition to BYOD support

Outcome Assessment Types and Role-Based Access

  • Supports electronic diaries (eDiaries) for longitudinal participant self-reporting
  • Clinician-reported outcomes (ClinRO) and caregiver workflows are supported with role-based access controls
  • Observer-Reported Outcomes (ObsRO) and Performance Outcomes (PerfO) are included within the platform's assessment scope
  • Each user role is provided tailored access to streamline workflow and maintain data privacy

Validated Instruments and Compliance

  • Integrates licensed and validated Clinical Outcome Assessment (COA) instruments with version control and permissions management
  • Supports compliance with global and local study requirements
  • Integration with MedDRA controlled vocabulary for reliable, standardized data capture

Jeeva eClinical Cloud is described as disease-agnostic and device-agnostic, and is designed to support decentralized or hybrid trial operations in a modular fashion. The platform is trusted by over 14,000 users and has been used across rare disease studies, investigator-initiated observational studies, and global clinical trials.

Meta

Domain
Clinical Trial Management
Subdomain
Patient-Reported Outcomes (ePRO/eCOA) & Patient Engagement
Software type(s)
Analytical Platform
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
BiotechCROMedical DevicesPharma
Development stage(s)
Clinical
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11HIPAAGDPRSOC 2