Decentralized Clinical Trial Software

Decentralized clinical trial software: 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

Decentralized Clinical Trial Software

Decentralized clinical trial software is one stack that supports remote participation, data capture, and consent—with 21 CFR Part 11–aligned controls and one audit trail. Definition: trials where some or all activities occur away from the traditional site. DCT use cases include remote consent, ePRO, and visit-based data capture. Operational complexity increases when consent, EDC, and ePRO are in separate systems. 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 DCT use cases

Decentralized trials (DCTs) allow participants to complete some or all activities remotely. Use cases include remote consent, ePRO, and visit-based data capture. When one stack covers consent, EDC, and ePRO, you get one audit trail and simpler operations; 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 decentralized 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 across consent and data capture
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 decentralized 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

Software for remote clinical trials Hybrid clinical trial software Features

FAQ

Questions we hear a lot

What is decentralized clinical trial software?

Decentralized clinical trial software 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.

How does Capture support DCTs?

Capture provides one platform for consent, EDC, and ePRO. Consent and data capture share one audit trail, so remote consent and subsequent data capture are traceable end to end.

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.