ePRO

Mahalo's ePRO (Electronic Patient-Reported Outcomes) is a digital clinical research platform designed for life sciences teams running patient-reported outcome studies and behavior intervention trials. It replaces paper-based survey workflows with a mobile-first, unified eClinical platform that covers survey creation, patient engagement, data management, stipend payments, and digital therapeutics (DTx) development.

The platform is positioned for academic researchers, clinical trial teams, and digital health companies that need to collect patient data, study behavior-modifying interventions, and bring FDA-approved DTx products to market — all within a single configurable system.

Survey Creation and Form Building

• Drag-and-drop editor for building eCRF surveys without programming knowledge
• Over 12 form field options available
• Field-level validation, check rules, and skip logic configurable through the interface
• Supports questions in any language
• No need to copy data from paper surveys

Patient Engagement and Data Collection

• Conversational, chat-like interface presents questions one at a time
• Participants respond with a single tap; rich media question types include pictures and videos
• Scheduled notification reminders for recurring measurements
• Multiple notifications can be triggered for a single survey
• Triggers can be set based on time, location, survey status, and other conditions
• Chat-based tools allow participants to ask questions directly
• Forum features support building a participant community for accountability

Data Management and Automation

• Integrates connected device data into individual participant records
• Ingests EHR records, test results, and patient diary text
• Fetches completed clinician and patient ePRO survey forms
• Allows selection of precise data fields required for a study
• Normalizes and maps data to each individual participant record
• Eliminates manual data transfer and reduces data entry errors through automated validations and edit checks

Participant Management

• Bulk invitations to participants
• Segmentation by demographics and study phase
• Real-time view of individual completed surveys
• Real-time study progress dashboard
• Comprehensive audit trail

Stipend Payment Automation

• PCI-compliant payment processing
• Storage of participant bank details
• Scheduling of weekly or monthly payouts
• Linking of study bank accounts
• Automatic retry of failed payments

Behavior Intervention and Digital Therapeutics Tools

• Built-in learning management system (LMS) with micro-learning features
• Personalized, data-driven behavior reinforcement
• Behavior tracking via connected devices
• Meal, weight, exercise, and sleep logging
• Personal coaching through telemedicine video or text chat
• Community features for participant accountability
• Supports deployment as a single app for academic studies or as separate research and therapy apps for clinical trials

Bringing a DTx Product to Market

• Branding of the DTx app with a company logo
• Study data can be used to support FDA approval
• Production mode launch for consumer-facing apps
• Integration with EHR systems to allow physicians to prescribe the DTx
• Ongoing data collection from patients using the commercial DTx product

Security and Compliance

• FDA 21 CFR Part 11 compliance
• HIPAA compliance
• Good Clinical Practice (GCP) adherence
• Data encryption in transit and at rest
• Two-factor authentication
• Automatic locking of completed surveys
• Automatic participant anonymization
• Real-time study data backup
• GDPR compliance and ISO compliance certificates available

Mahalo is described as a unified platform covering eClinical data management, DTx development, and a unified data layer, supporting use cases across clinical research and commercial digital health applications. The platform is available across the Americas, Europe, Middle East, Africa, and Asia-Pacific regions.