EDC for Wearable Device Studies

EDC for wearable device studies: wearables, 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 Wearable Device Studies

Wearable device studies use wearables and sensors to collect continuous or periodic data alongside clinical and patient-reported endpoints. Your EDC must support consent, CRFs, ePRO, and integration or capture of wearable/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 wearable study teams can capture clinical and ePRO data with one audit trail; wearable data can be integrated or documented as required by protocol.

Why wearable device studies need the right EDC

Wearable studies combine clinical visits with device and ePRO data. You need one system that handles consent, CRFs, and ePRO with the same audit trail and access controls. Standalone device platforms often don’t integrate with EDC. Capture integrates ePRO with EDC and eConsent so patient-reported and visit-based data are captured with the same controls and audit history; wearable data can be linked or imported as your protocol requires.

Common wearable device study workflow

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

Traditional tool pain points

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

How Capture supports wearable device studies

  • Unified EDC with eConsent and ePRO; one platform for clinical and ePRO 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 mobile health studiesFeatures

FAQ

Questions we hear a lot

Is Capture suitable for wearable device 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 ePRO data; wearable data can be integrated or documented as needed.
Do we need a separate wearable platform?
Capture includes ePRO for patient-reported data. For wearable or device data, you can capture or integrate as your protocol requires. 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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