Clinical Trial Patient Enrollment Software

Clinical trial patient enrollment software: screening, consent, and enrollment in one platform with 21 CFR Part 11–aligned controls.

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

Overview

Clinical Trial Patient Enrollment Software

Clinical trial patient enrollment software covers screening, consent, and enrollment in one workflow—with 21 CFR Part 11–aligned controls and one audit trail when integrated with EDC and ePRO. Common blockers include manual screening, paper consent, and fragmented systems. What software changes is one platform for eligibility checks, consent, and baseline visits—so sites and patients have a simpler path to enrollment. Capture provides enrollment workflows in the same platform as EDC, eConsent, and ePRO—one audit trail and same security.

What this workflow covers

Patient enrollment spans pre-screening, eligibility checks, consent, and baseline visit data. When enrollment is in the same platform as EDC and eConsent, you get one audit trail and one build; when it’s separate, you get integration cost and two audit trails. Teams want to reduce manual screening and make enrollment easier for sites and patients.

Common blockers and what software changes

  • Manual screening and paper forms: slow, error-prone, no single audit trail
  • One platform for screening, consent, and enrollment; one audit trail
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security as EDC and eConsent
  • Eligibility and enrollment data in same system as CRFs
  • Documentation to support sponsor validation when required (Enterprise)

Common blockers

  • Manual screening and paper consent slow enrollment
  • Separate screening or enrollment system: two audit trails and reconciliation
  • Sites and patients juggling multiple systems
  • Need for one platform for screening, consent, and data capture with one audit trail

Capture workflow for patient enrollment

  • Screening, consent, and enrollment in same platform as EDC and ePRO; one audit trail
  • Study builder to configure eligibility and enrollment workflows
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore workflow or book a demo

Related

EDC with patient enrollment toolseConsent software for clinical trialsFeatures

FAQ

Questions we hear a lot

What is clinical trial patient enrollment software?
Patient enrollment software supports screening, consent, and enrollment in one workflow—with 21 CFR Part 11–aligned controls. Capture includes enrollment workflows in the same platform as EDC, eConsent, and ePRO.
Is enrollment data auditable?
Yes. All screening and enrollment data in Capture 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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