EDC with Patient Enrollment Tools

EDC with patient enrollment tools: screening, consent, and data capture in one platform with 21 CFR Part 11–aligned controls.

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

Overview

EDC with Patient Enrollment Tools

EDC with patient enrollment tools means screening, consent, and data capture in one platform—eligibility checks, consent, and baseline visits in one workflow and one audit trail. Teams want it to simplify site and sponsor workflows and keep enrollment data with the rest of the study. Capture provides EDC, eConsent, ePRO, and safety in one platform with study builder to configure screening and enrollment; 21 CFR Part 11–aligned controls and HIPAA-aligned security apply to all data.

Why teams want EDC with enrollment tools

Separate screening or enrollment systems mean extra integration and audit trails. Built-in enrollment workflows give you screening and consent in the same platform as CRFs—one build and one audit trail. Operational benefits include faster setup, simpler monitoring, and consistent data integrity for regulatory and sponsor review.

Operational benefits of EDC with enrollment tools

  • One platform for screening, consent, and CRFs; one audit trail
  • Configure eligibility and enrollment workflows in study builder
  • 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 enrollment

  • Separate screening or enrollment system and integration
  • Two audit trails and reconciliation for enrollment and data
  • Higher cost and longer implementation for enrollment workflows
  • Monitoring and compliance review across multiple systems

Capture workflow for EDC with enrollment tools

  • Study builder to configure screening, consent, and visit-based data capture in one platform
  • One audit trail for all data; 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Flexible forms and visits for eligibility and enrollment
  • Export for analysis and regulatory use; documentation for validation (Enterprise)

FAQ

Questions we hear a lot

What are patient enrollment tools in Capture?
Capture includes study builder to configure screening, consent, and visit-based data capture. Eligibility and enrollment workflows are in the same platform as CRFs, with one audit trail.
Is enrollment data auditable?
Yes. All screening and enrollment data is recorded in the audit trail with the same 21 CFR Part 11–aligned 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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