Clinical Trial Software with Integrated ePRO

Clinical trial software with integrated ePRO: one platform for EDC, 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

Clinical Trial Software with Integrated ePRO

Clinical trial software with integrated ePRO means EDC and patient-reported outcomes in the same platform—one audit trail, one build, and no separate ePRO vendor. Teams want it to simplify compliance and reduce cost. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned security, so you get integrated ePRO without stitching systems together.

Why teams want integrated ePRO

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

Operational benefits of integrated 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 integrated 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 integrated ePRO

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

Related

EDC with built-in ePROePRO for patient-reported outcome studiesFeatures

FAQ

Questions we hear a lot

What is integrated ePRO?
Integrated ePRO means patient-reported outcomes (ePRO/eCOA) in the same platform as EDC and eConsent—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.