EDC for Supplement Clinical Trials

EDC for supplement clinical trials: dietary supplement studies with 21 CFR Part 11–aligned controls and one platform.

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

Overview

EDC for Supplement Clinical Trials

Supplement clinical trials evaluate the safety and efficacy of dietary supplements in human subjects. Your EDC must support consent, CRFs, compliance and adherence capture, safety and AE reporting, and full auditability for regulatory and publication use. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so supplement study teams can run compliant trials without enterprise cost.

Why supplement trials need the right EDC

Supplement studies often have smaller budgets and need flexible build for compliance, safety, and optional ePRO. You need one system that handles consent and data capture without lengthy implementation or per-seat pricing. Enterprise EDC often targets pharma with pricing that doesn’t fit. Capture is built for supplement and nutraceutical studies with controls aligned with 21 CFR Part 11 and pricing that scales with study size.

Common supplement trial workflow

  • Protocol and consent; ethics and regulatory approvals
  • Site activation and enrollment
  • Baseline and on-treatment data; compliance and adherence
  • Safety and AE capture; optional ePRO
  • Data review and query resolution
  • Database lock and export for analysis and regulatory use

Traditional tool pain points

  • Enterprise EDC pricing that doesn’t fit supplement budgets
  • Long implementation for dietary supplement studies
  • Separate ePRO and EDC systems
  • Limited support for compliance and adherence tracking

How Capture supports supplement trials

  • Unified EDC with eConsent and ePRO; flexible forms for compliance and safety
  • One platform and one audit trail for all data
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Export for analysis and regulatory use; documentation for validation (Enterprise)

Related

EDC for nutraceutical clinical trialsFeaturesPricing

FAQ

Questions we hear a lot

Is Capture suitable for supplement clinical trials?
Yes. Capture supports supplement studies with flexible EDC, eConsent, and ePRO. You get 21 CFR Part 11–aligned controls and one audit trail. Many supplement studies use Capture for efficacy and safety trials.
Can we track compliance and adherence?
Yes. You can design forms for supplement intake, adherence, and compliance. ePRO can support diaries and questionnaires. All data is captured with full audit history.
What about compliance?
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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