EDC for Mobile Health Studies

EDC for mobile health studies: mHealth, ePRO, and 21 CFR Part 11–aligned controls in one platform.

21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required

Overview

EDC for Mobile Health Studies

Mobile health (mHealth) studies use smartphones and mobile apps to collect patient-reported and sometimes device data. Your EDC must support consent, CRFs, ePRO, and mobile data capture with full auditability. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so mHealth study teams can capture clinical and mobile data with one audit trail and one system.

Why mHealth studies need the right EDC

mHealth trials combine clinical visits with mobile-based ePRO or app data. You need one system that handles consent, CRFs, and ePRO with the same audit trail and access controls. Standalone mobile or ePRO platforms often don’t integrate with EDC. Capture integrates ePRO with EDC and eConsent so mobile health data is captured with the same controls and audit history as clinical data.

Common mHealth study workflow

  • Protocol and consent; ePRO and mobile endpoint configuration
  • Enrollment and ePRO/mobile data scheduling
  • Clinical and mobile-based data capture
  • Data review and queries; integration of sources
  • Database lock and export for analysis and regulatory use

Traditional tool pain points

  • Separate mobile/ePRO and EDC systems; no single audit trail
  • High cost and complex integration for mobile endpoints
  • Limited flexibility for mobile schedule and instrument changes
  • Overbuilt enterprise solutions for mHealth scope

How Capture supports mHealth studies

  • Unified EDC with eConsent and ePRO; one platform for clinical and mobile data
  • One audit trail for all data; 21 CFR Part 11–aligned controls
  • HIPAA-aligned security; export for analysis and regulatory use
  • Documentation for sponsor validation (Enterprise)

Related

EDC for digital health clinical trialsEDC for wearable device studiesFeatures

FAQ

Questions we hear a lot

Is Capture suitable for mobile health studies?
Yes. Capture includes ePRO in the same platform as EDC and eConsent. You get one audit trail and 21 CFR Part 11–aligned controls for clinical and mobile-based data.
Do we need a separate mobile platform?
Capture includes ePRO for questionnaires and diaries that can be used on mobile. Data is captured with the same audit and security controls as the rest of the study.
What about compliance?
Capture is designed with 21 CFR Part 11–aligned controls and HIPAA-aligned security. We provide documentation to support sponsor validation when required (Enterprise).

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