ePRO for Small Clinical Trials

ePRO for small 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 Small Clinical Trials

ePRO for small clinical trials lets you collect patient-reported outcomes without enterprise ePRO pricing or separate vendors—questionnaires, diaries, symptom tracking—with 21 CFR Part 11–aligned controls and one audit trail when integrated with EDC and eConsent. Small trials need one platform that scales with cohort size. 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 small and early-phase trials.

Why small trials want ePRO

Small clinical trials need participant-reported data with full audit trail and 21 CFR Part 11–aligned controls—without enterprise ePRO minimums or separate vendor integration. 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 for small trials

  • 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
  • Pricing and support that scale with small trial size
  • 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 cost for small trials
  • Enterprise ePRO minimums that don’t fit small trial budget
  • Need for one platform for consent, CRFs, and ePRO with one audit trail

Capture approach to ePRO for small trials

  • ePRO in same platform as EDC and eConsent; one audit trail; built for small trials
  • 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

Clinical trial platform for small studiesePRO software for clinical trialsFeatures

FAQ

Questions we hear a lot

What is ePRO for small clinical trials?
ePRO for small trials lets you collect patient-reported outcomes without separate ePRO vendors—with 21 CFR Part 11–aligned controls. Capture includes ePRO in the same platform as EDC and eConsent, built for small trials.
Do I need a separate ePRO vendor for small trials?
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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