EDC

Mahalo's Electronic Data Capture (EDC) system is a clinical data collection platform designed for researchers and study participants in decentralized, hybrid, and traditional clinical research settings. It combines eCRF building, eConsent, eCOA, eSource, and ePro capabilities within a single interface, with the stated goal of reducing the time from study creation to deployment.

The platform is intended for research teams that need to collect data from multiple sources — including patient-reported outcomes, clinician entries, connected devices, and electronic health records — and consolidate that data into a unified clinical database.

Study Building and Configuration

• Drag-and-drop survey builder for creating eCRFs, with 12 available form field types
• Study templates available as a starting point
• Set minimum and maximum limits for individual form fields
• Skip logic to bypass future questions based on prior answers
• Question weighting and automatic score calculation for completed surveys
• User-friendly admin panel for configuring all aspects of a study

User Roles and Permissions

• Individual access configuration by user role
• Admin access controls
• Participant assignment to specific researchers or clinicians
• Configurable visibility of surveys (eCRFs) by user role
• Custom user rights and workflow rules for data collection
• Ability to manage multiple studies under a single account

Data Collection and Integration

• Supports patient surveys completed at clinics, pharmacies, or at home via self-reporting or telehealth appointments
• Ingests data from IoT-connected medical devices, scales, and wearables
• Pulls medical records and lab results from EHR systems including EPIC and Cerner
• Captures patient and clinician-reported data, patient diaries, and in-app chat history
• Supports unlimited data point collection per participant
• Permission-based data import and export in CSV or Excel formats

Recurring Measurement Capture

• Lab test results
• Connected device readings
• Changes to medical history
• Unscheduled medical visits
• Adverse events

Data Monitoring and Quality

• Real-time dashboard for tracking overall study progress
• Tracking of data anomalies
• Individual participant progress views
• In-app chat for managing and responding to participant questions
• Edit checks and validation rules applied in real-time as data is entered
• Auto-lock of data upon survey submission, with user permissions required to unlock
• Full audit trail for all changes made to captured data
• Real-time authentication to verify subject enrollment

Randomization

• Weighted randomization
• Blinded randomization
• Automatic participant anonymization

Security and Compliance

• Data encryption in transit and at rest
• Two-factor authentication
• FDA 21 CFR Part 11 compliance
• HIPAA compliance
• Good Clinical Practice (GCP) compliance
• Real-time study data backup

Mahalo EDC is part of the broader Mahalo Health unified digital health platform, which also covers DTx development and a unified data platform. The system is available across the Americas, Europe, the Middle East, Africa, and Asia-Pacific regions.