Remote Patient Monitoring for Clinical Trials

Remote patient monitoring for clinical trials: consent, ePRO, and data capture in one platform. 21 CFR Part 11–aligned controls.

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

Overview

Remote Patient Monitoring for Clinical Trials

Remote patient monitoring for clinical trials uses one stack for consent, ePRO, and visit-based data capture—so participant touchpoints are in one platform with 21 CFR Part 11–aligned controls and one audit trail. DCT use cases include remote consent and patient-reported data. 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

Remote patient monitoring in clinical trials means capturing consent and patient-reported or visit-based data remotely. 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 and patient-reported data in one platform and one audit trail
  • Consent, data capture, and patient touchpoints with same 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • 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 patient touchpoints
  • 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 patient monitoring

  • 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 remote patient monitoring for clinical trials?
Remote patient monitoring for clinical trials uses one stack for consent, ePRO, and data capture—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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