EDC with Built-in ePRO

EDC with built-in ePRO: one platform for data capture, eConsent, and patient-reported outcomes with 21 CFR Part 11–aligned controls.

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

Overview

EDC with Built-in ePRO

EDC with built-in ePRO means electronic data capture and patient-reported outcomes in the same platform—one audit trail, one build, and no separate ePRO vendor. Teams want it to simplify compliance, reduce integration cost, and give sites and participants a single experience. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned security, so you can run studies with built-in ePRO without stitching systems together.

Why teams want EDC with built-in ePRO

Separate EDC and ePRO systems mean two audit trails, two vendors, and complex reconciliation. Built-in ePRO gives you questionnaires, diaries, and PRO instruments in the same platform as CRFs and consent—same audit trail, same security, and one build. Operational benefits include faster setup, simpler monitoring, and consistent data integrity for regulatory and sponsor review.

Operational benefits of built-in ePRO

  • One platform and one audit trail for CRFs, consent, and ePRO
  • Configure and schedule PRO instruments without separate vendor
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security for all data
  • Simpler monitoring and query resolution; export for analysis and regulatory use
  • Documentation to support sponsor validation when required (Enterprise)

What slows teams down without built-in ePRO

  • Separate ePRO vendor and integration project
  • Two audit trails and complex data reconciliation
  • Higher cost and longer implementation for PRO endpoints
  • Monitoring and compliance review across multiple systems

Capture workflow for EDC with built-in ePRO

  • Built-in ePRO and eCOA: questionnaires, diaries, and PRO instruments in same platform as EDC and eConsent
  • One audit trail for all data; 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Study builder to configure visits, forms, and ePRO schedules
  • Export for analysis and regulatory use; documentation for validation (Enterprise)

Related

Clinical trial software with integrated ePROEDC with eConsentFeatures

FAQ

Questions we hear a lot

What is EDC with built-in ePRO?
EDC with built-in ePRO means electronic data capture and patient-reported outcomes (ePRO/eCOA) in the same platform—one audit trail and one build. Capture includes ePRO in the same system as EDC and eConsent.
Do I need a separate ePRO vendor?
No. Capture includes ePRO. Questionnaires, diaries, and PRO instruments can be configured and scheduled. Data is captured with the same audit 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).

Ready to see Capture in action?

Explore the platform with a free sandbox. No sales call required.