ePRO Software for Clinical Trials

ePRO software for clinical trials: collect patient-reported data digitally with 21 CFR Part 11–aligned controls. Integrated with EDC and eConsent.

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

Overview

ePRO Software for Clinical Trials

ePRO software for clinical trials lets teams collect patient-reported outcomes digitally—questionnaires, diaries, symptom tracking—with 21 CFR Part 11–aligned controls and one audit trail. Common workflows include scheduling PRO instruments by visit, capturing data on device or web, and keeping participants compliant. Paper and app fragmentation cause issues: multiple systems, no single audit trail, and complex reconciliation. Capture’s approach is ePRO built into the same platform as EDC and eConsent—one audit trail, same security, and no separate ePRO vendor.

What is ePRO and why teams want it

ePRO (electronic patient-reported outcomes) is the digital collection of patient-reported data—symptoms, diaries, questionnaires—for clinical trials. Teams want it to improve data quality, reduce missing data, and keep participants compliant. When ePRO is in the same platform as EDC and eConsent, you get one audit trail and one build; when it’s separate, you get integration cost and two audit trails.

Common ePRO workflows

  • Schedule PRO instruments by visit or time window
  • Capture patient-reported data on device or web with full audit trail
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security as EDC and eConsent
  • Query and monitor compliance; export for analysis and regulatory use
  • Documentation to support sponsor validation when required (Enterprise)

Why paper and app fragmentation cause issues

  • Paper PROs: transcription errors, missing data, no single audit trail
  • Separate ePRO app or vendor: two systems, two audit trails, integration and reconciliation
  • Participant non-compliance and fragmented data across systems
  • Need for one platform for consent, CRFs, and ePRO with one audit trail

Capture approach to ePRO

  • ePRO built into same platform as EDC and eConsent; one audit trail for all data
  • Questionnaires, diaries, and PRO instruments configurable in study builder
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore ePRO or book a demo

Related

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FAQ

Questions we hear a lot

What is ePRO software for clinical trials?
ePRO software collects patient-reported outcomes (e.g., questionnaires, diaries, symptom tracking) digitally for clinical trials—with 21 CFR Part 11–aligned controls. Capture includes ePRO in the same platform as EDC and eConsent.
Do I need a separate ePRO vendor?
No. Capture includes ePRO. You can configure and schedule PRO instruments; data is captured with the same audit trail and security controls as the rest of the study.
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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