Hybrid Clinical Trial Software

Hybrid clinical trial software: one stack for site and remote participation, consent, and data capture. 21 CFR Part 11–aligned controls.

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

Overview

Hybrid Clinical Trial Software

Hybrid clinical trial software supports trials that combine site and remote participation—one stack for consent, data capture, and ePRO with 21 CFR Part 11–aligned controls and one audit trail. DCT use cases include hybrid designs where some visits are on-site and some remote. Operational complexity increases when systems are separate. Core workflows need one platform for consent, CRFs, and patient touchpoints. Capture fits: EDC, eConsent, ePRO in one platform with end-to-end remote workflow and one audit trail.

Definition and use cases for hybrid trials

Hybrid trials combine site and remote participation. When one stack covers consent, EDC, and ePRO, you get one audit trail for both site and remote touchpoints; when systems are separate, you get operational complexity and multiple audit trails.

Operational complexity and core workflows

  • Site and remote consent, data capture, and patient-reported data in one platform and one audit trail
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security for all touchpoints
  • Support for hybrid trial designs
  • Documentation to support sponsor validation when required (Enterprise)

Operational complexity without one stack

  • Separate consent, EDC, and ePRO: multiple audit trails and reconciliation
  • No single view of site and remote workflow
  • Need for one platform for consent, CRFs, and ePRO with one audit trail
  • Capture: one stack for EDC, eConsent, ePRO; end-to-end remote workflow

Capture fit for hybrid trials

  • One platform for EDC, eConsent, ePRO, and safety; one audit trail for site and remote consent and data capture
  • End-to-end remote workflow across consent, data capture, and patient touchpoints
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore remote trial workflows or book a demo

Related

Decentralized clinical trial softwareEDC for hybrid clinical trialsFeatures

FAQ

Questions we hear a lot

What is hybrid clinical trial software?
Hybrid clinical trial software supports trials that combine site and remote participation—with one stack for consent, data capture, and ePRO and 21 CFR Part 11–aligned controls. Capture includes EDC, eConsent, and ePRO in one platform with end-to-end remote workflow.
Is Capture 21 CFR Part 11–aligned?
Yes. 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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