Digital Clinical Trial Platforms

Digital clinical trial platforms: one stack for consent, data capture, and ePRO. 21 CFR Part 11–aligned controls.

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

Overview

Digital Clinical Trial Platforms

Digital clinical trial platforms provide one stack for consent, data capture, and ePRO—with 21 CFR Part 11–aligned controls and one audit trail. Definition and use cases align with modern, digitally enabled trials including remote and hybrid. Operational complexity increases when systems are separate. Core workflows need one platform. Capture fits: EDC, eConsent, ePRO in one platform with end-to-end remote workflow and one audit trail.

Definition and use cases

Digital clinical trial platforms support consent, data capture, and ePRO in one flow. When one stack covers all touchpoints, you get one audit trail; when systems are separate, you get operational complexity and multiple audit trails.

Operational complexity and core workflows

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 remote and hybrid designs
Documentation to support sponsor validation when required (Enterprise)

Operational complexity without one stack

Separate consent, EDC, and ePRO: multiple audit trails and reconciliation
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 digital clinical trial platforms

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

Decentralized clinical trial software Virtual clinical trial platforms Features

FAQ

Questions we hear a lot

What are digital clinical trial platforms?

Digital clinical trial platforms provide one stack for consent, data capture, and ePRO—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).

Ready to see Capture in action?

Explore the platform with a free sandbox. No sales call required.