EDC for Digital Health Clinical Trials

EDC for digital health clinical trials: ePRO, device data, 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 Digital Health Clinical Trials

Digital health clinical trials use digital tools—ePRO, apps, wearables, or other sensors—to collect patient-reported and device data. Your EDC must support consent, CRFs, ePRO, and optional device or sensor data 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 digital health trial teams can capture clinical and digital data with one audit trail and one system.

Why digital health trials need the right EDC

Digital health trials often combine clinical visits with ePRO, apps, or device data. You need one system that handles consent, CRFs, and ePRO with the same audit trail and access controls. Standalone ePRO or device platforms often don’t integrate with EDC, complicating monitoring and regulatory review. Capture integrates ePRO with EDC and eConsent so digital health data is captured with the same controls and audit history as clinical data.

Common digital health trial workflow

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

Traditional tool pain points

  • Separate ePRO, device, and EDC systems; no single audit trail
  • High cost and complex integration for digital endpoints
  • Limited flexibility for ePRO and digital schedule changes
  • Overbuilt enterprise solutions for digital health scope

How Capture supports digital health trials

  • Unified EDC with eConsent and ePRO; one platform for clinical and PRO 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 mobile health studiesEDC for wearable device studiesFeatures

FAQ

Questions we hear a lot

Is Capture suitable for digital health clinical trials?
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 patient-reported data.
Do we need a separate ePRO or device platform?
Capture includes ePRO. For device or sensor data, you can capture or integrate as needed. We provide one platform for clinical and ePRO data with the same audit and security controls.
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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