EDC for Nutraceutical Clinical Trials

EDC for nutraceutical clinical trials: dietary supplement and functional food studies with 21 CFR Part 11–aligned controls.

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

Overview

EDC for Nutraceutical Clinical Trials

Nutraceutical clinical trials evaluate dietary supplements, functional foods, and related products in human subjects. Your EDC must support consent, CRFs, safety and compliance capture, 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 nutraceutical study teams can run compliant trials without enterprise cost.

Why nutraceutical trials need the right EDC

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

Common nutraceutical trial workflow

  • Protocol and consent; ethics and regulatory approvals
  • Site activation and enrollment
  • Baseline and on-treatment data; compliance and adherence capture
  • 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 nutraceutical budgets
  • Long implementation for supplement and functional food studies
  • Separate ePRO and EDC systems
  • Limited support for compliance and adherence tracking

How Capture supports nutraceutical 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 supplement clinical trialsFeaturesPricing

FAQ

Questions we hear a lot

Is Capture suitable for nutraceutical clinical trials?
Yes. Capture supports nutraceutical and 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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