EDC for Hybrid Clinical Trials

EDC for hybrid clinical trials: site and remote workflows, consent, and ePRO 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 Hybrid Clinical Trials

Hybrid clinical trials combine on-site visits with remote consent, telemedicine, or patient-reported data capture. Your EDC must support both site-based and remote workflows in one system so consent, CRFs, and ePRO share one audit trail. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so hybrid trial teams can run end-to-end workflows across site and remote touchpoints without stitching together multiple vendors.

Why hybrid trials need the right EDC

Hybrid trials require one system that supports both site and remote touchpoints—consent (on-site or remote), CRFs, and ePRO—with one audit trail. Legacy setups often combine separate eConsent, EDC, and ePRO tools, complicating hybrid workflows and monitoring. Capture is built for end-to-end workflow: electronic consent, visit-based and ePRO data capture, and optional remote touchpoints in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned security.

Common hybrid trial workflow

Protocol and consent; on-site or remote consent and e-signature
Site and optional remote enrollment; patient onboarding
Site visits and optional remote/ePRO 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 for site and remote workflows
High cost for hybrid or multi-vendor stacks
Limited support for mixed site and remote touchpoints

How Capture supports hybrid trials

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

EDC for decentralized clinical trials EDC for remote clinical trials Features

FAQ

Questions we hear a lot

Is Capture suitable for hybrid clinical trials?

Yes. Capture supports hybrid trials with eConsent, EDC, and ePRO in one platform. You get one audit trail for site and remote data with 21 CFR Part 11–aligned controls.

How do site and remote workflows work together?

Capture includes electronic consent and ePRO in the same platform as EDC. Site and remote data are captured with the same audit trail and security controls, so hybrid 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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