ePRO for Phase 1 Clinical Trials

ePRO for Phase 1 clinical trials: patient-reported outcomes 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 for Phase 1 Clinical Trials

ePRO for Phase 1 clinical trials lets you collect patient-reported outcomes in early-phase studies—questionnaires, diaries, symptom tracking—with 21 CFR Part 11–aligned controls and one audit trail when integrated with EDC and eConsent. Phase 1 often has dense safety and PK data; ePRO adds participant-reported endpoints without a separate vendor. Paper and app fragmentation cause issues. Capture provides ePRO in the same platform as EDC and eConsent—one audit trail and same security, built for Phase 1.

Why Phase 1 teams want ePRO

Phase 1 studies need participant-reported data for tolerability, symptoms, or diaries—with full audit trail and 21 CFR Part 11–aligned controls. When ePRO is in the same platform as EDC and eConsent, you get one build and one audit trail; when it’s separate, you get integration cost and two audit trails.

Common ePRO workflows in Phase 1

  • Schedule PRO instruments by visit or time window; same platform as CRFs and consent
  • Capture patient-reported data with full audit trail
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security as EDC and eConsent
  • Query and 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 vendor: two systems, two audit trails, integration and reconciliation
  • Phase 1 timelines and budget pressure with multiple vendors
  • Need for one platform for consent, CRFs, and ePRO with one audit trail

Capture approach to ePRO for Phase 1

  • ePRO in same platform as EDC and eConsent; one audit trail; built for Phase 1
  • 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

EDC for Phase 1 clinical trialsePRO software for clinical trialsFeatures

FAQ

Questions we hear a lot

What is ePRO for Phase 1 clinical trials?
ePRO for Phase 1 lets you collect patient-reported outcomes in early-phase trials—with 21 CFR Part 11–aligned controls. Capture includes ePRO in the same platform as EDC and eConsent, built for Phase 1.
Do I need a separate ePRO vendor for Phase 1?
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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