Software for Remote Clinical Trials

Software for remote clinical trials: one stack for 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

Software for Remote Clinical Trials

Software for remote clinical trials provides one stack for remote participation, data capture, and consent—with 21 CFR Part 11–aligned controls and one audit trail. Remote trials need consent, EDC, and ePRO in one flow so the entire patient journey is traceable. 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 remote trials

Remote trials allow participants to complete some or all activities away from the traditional site. When one stack covers consent, EDC, and ePRO, you get one audit trail; when systems are separate, you get operational complexity and multiple audit trails.

Operational complexity and core workflows

  • Remote consent with version control and e-signature; full audit trail
  • 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 and fully remote 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 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 remote trials

  • One platform for EDC, eConsent, ePRO, and safety; one audit trail for 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

FAQ

Questions we hear a lot

What is software for remote clinical trials?
Software for remote clinical trials is one stack that supports remote participation, data capture, and consent—with 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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