Software for Investigator-Initiated Trials

Software for investigator-initiated trials: EDC, eConsent, ePRO with 21 CFR Part 11–aligned controls. Lean teams, budget sensitivity.

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

Overview

Software for Investigator-Initiated Trials

Software for investigator-initiated trials (IITs) supports investigator-led studies with one platform for EDC, eConsent, and ePRO—with 21 CFR Part 11–aligned controls and fit for lean teams and smaller budgets. Why academic studies differ: IITs are often investigator-led, budget-sensitive, and lean staffing. Budget and staffing realities mean IIT teams need one system without enterprise pricing. Capture fit: one platform for EDC, eConsent, ePRO; pricing and support that fit investigator-led use; documentation for sponsor validation when required (Enterprise).

Why academic and IIT studies differ

Investigator-initiated trials are often investigator-led, with lean teams and budget sensitivity. Teams need one platform for consent and data capture—with full audit trail and 21 CFR Part 11–aligned controls—without enterprise pricing or long implementation.

Budget and staffing realities

  • One platform for EDC, eConsent, ePRO; one audit trail
  • Pricing and support that fit IIT and academic budgets and lean teams
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Study builder for investigator-led build and amendments
  • Documentation to support sponsor validation when required (Enterprise)

Key pain points

  • Enterprise software pricing that doesn’t fit IIT budgets
  • Long implementation for lean teams
  • Need for one platform for consent, CRFs, and ePRO with one audit trail
  • Capture: fit for investigator-initiated use

Capture fit for investigator-initiated trials

  • One platform for EDC, eConsent, ePRO; fit for investigator-initiated and academic use
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Pricing and support that fit lean teams and IIT budgets
  • Explore use case or book a demo

Related

EDC for investigator-initiated trialsClinical trial software for universitiesFeatures

FAQ

Questions we hear a lot

What is software for investigator-initiated trials?
Software for investigator-initiated trials supports IITs with one platform for EDC, eConsent, and ePRO—with 21 CFR Part 11–aligned controls and fit for lean teams and IIT budgets.
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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