ePRO Software Without App Development

ePRO software without app development: collect patient-reported data with 21 CFR Part 11–aligned controls. No custom app build. Integrated with EDC and eConsent.

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

Overview

ePRO Software Without App Development

ePRO software without app development lets you collect patient-reported outcomes without building or maintaining a custom app—questionnaires, diaries, symptom tracking—with 21 CFR Part 11–aligned controls and one audit trail when integrated with EDC and eConsent. Teams want compliant ePRO without the cost and delay of custom app development. Paper and app fragmentation cause issues. Capture provides ePRO in the same platform as EDC and eConsent—configurable in study builder, no custom app required.

Why teams want ePRO without app development

Custom ePRO apps require development, maintenance, and validation. When ePRO is built into the same platform as EDC and eConsent, you get configurable instruments and diaries without custom app development—with full audit trail and 21 CFR Part 11–aligned controls. One platform means one build and one audit trail.

Common ePRO workflows without custom app

  • Configure and schedule PRO instruments in study builder; no custom app build
  • 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

  • Custom app development: cost, delay, and validation burden
  • Paper PROs: transcription errors, missing data, no single audit trail
  • Separate ePRO app or vendor: two systems, two audit trails
  • Need for one platform for consent, CRFs, and ePRO with one audit trail

Capture approach to ePRO without app development

  • ePRO in same platform as EDC and eConsent; configurable in study builder; no custom app required
  • Questionnaires, diaries, and PRO instruments configurable without development
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore ePRO or book a demo

Related

ePRO software for clinical trialsEDC with study builderFeatures

FAQ

Questions we hear a lot

What is ePRO software without app development?
ePRO without app development means you can collect patient-reported outcomes using a configurable platform—no custom app build. Capture includes ePRO in the same platform as EDC and eConsent; you configure instruments in the study builder.
Do I need to build a custom app for ePRO?
No. Capture includes ePRO. You can configure and schedule PRO instruments in the study builder; 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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