EDC for University Clinical Studies

EDC for university clinical studies: lean teams, budget sensitivity, investigator-led workflows, and 21 CFR Part 11–aligned controls.

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

Overview

EDC for University Clinical Studies

University clinical studies are run by academic institutions with lean teams and budget sensitivity. Your EDC must support consent, CRFs, optional ePRO, and safety with full auditability—without enterprise pricing or long implementation. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so university teams can run compliant, investigator-led studies with pricing that scales with study size.

Why university studies need the right EDC

University and investigator-led studies often have limited budget and small teams. You need one system that handles consent, data capture, and optional ePRO without lengthy implementation or per-seat pricing. Enterprise EDC often targets industry with pricing and processes that don’t fit investigator-led workflows. Capture is built for university and academic studies with lean teams, budget sensitivity, and documentation to support validation when required.

Common university clinical study workflow

  • Protocol and consent; ethics and institutional approvals
  • Site activation (often single or few sites)
  • Screening, consent, and enrollment
  • Visit-based data collection; safety and AE capture; optional ePRO
  • Data review and query resolution
  • Database lock and export for analysis and publication

Traditional tool pain points

  • Enterprise EDC pricing that doesn’t fit university budgets
  • Long implementation and heavy change control
  • Separate ePRO and EDC systems
  • Limited support for lean, investigator-led teams

How Capture supports university clinical studies

  • Unified EDC, eConsent, ePRO, and safety in one platform
  • Rapid build and amendments with full audit trail
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Pricing that scales with study size; export for analysis and publication
  • Documentation for sponsor validation (Enterprise)

Related

EDC for academic clinical trialsEDC for investigator-initiated trialsFor academia

FAQ

Questions we hear a lot

Is Capture suitable for university clinical studies?
Yes. Capture is designed for university and academic studies. We emphasize lean teams, budget sensitivity, and investigator-led workflows. You get one platform with 21 CFR Part 11–aligned controls.
How do we support lean university teams?
Study build can start once you have protocol and CRF requirements. Many university teams deploy in weeks. We provide documentation to support validation when required (Enterprise).
What about compliance?
Capture is designed with 21 CFR Part 11–aligned controls and HIPAA-aligned security. We provide documentation to support your validation approach.

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