EDC for Remote Clinical Trials

EDC for remote clinical trials: remote consent, data capture, and patient touchpoints in one platform with 21 CFR Part 11–aligned controls.

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

Overview

EDC for Remote Clinical Trials

Remote clinical trials minimize or eliminate in-person site visits by using remote consent, telemedicine, and patient-reported or home-based data capture. Your EDC must support electronic consent, remote visit and ePRO workflows, and full auditability so the entire patient journey is traceable. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so remote trial teams can run end-to-end remote workflows across consent, data capture, and patient touchpoints without stitching together multiple vendors.

Why remote trials need the right EDC

Remote trials require consent, CRFs, and ePRO in one flow so patients have a single experience and one audit trail. Legacy setups often combine separate eConsent, EDC, and ePRO tools, complicating remote workflows and monitoring. Capture is built for end-to-end remote workflow: electronic consent, visit-based and ePRO data capture, and patient-facing touchpoints in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned security.

Common remote trial workflow

  • Protocol and consent; remote consent and e-signature
  • Patient enrollment and onboarding; optional patient portal
  • Remote visits; ePRO and patient-reported data capture
  • Safety and AE capture; data review and queries
  • Database lock and export for analysis and regulatory use

Traditional tool pain points

  • Separate eConsent, EDC, and ePRO systems; no single audit trail
  • Complex integration and patient experience across vendors
  • High cost for remote or multi-vendor stacks
  • Limited support for end-to-end remote workflow

How Capture supports remote trials

  • Unified EDC, eConsent, and ePRO; one platform for consent, CRFs, and patient-reported data
  • End-to-end remote workflow; one audit trail for all patient touchpoints
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Export for analysis and regulatory use; documentation for validation (Enterprise)

FAQ

Questions we hear a lot

Is Capture suitable for remote clinical trials?
Yes. Capture supports remote trials with eConsent, EDC, and ePRO in one platform. You get end-to-end remote workflow and one audit trail with 21 CFR Part 11–aligned controls.
How do remote consent and ePRO work together?
Capture includes electronic consent and ePRO in the same platform as EDC. Consent and patient-reported data are captured with the same audit trail and security controls, so remote workflows are traceable end to end.
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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