Tools Needed to Run a Clinical Trial
Tools needed to run a clinical trial: overview, tool categories, and what teams need. EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls.
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Overview
Tools Needed to Run a Clinical Trial
Tools needed to run a clinical trial include EDC, eConsent, ePRO, and often enrollment and randomization—in one platform with 21 CFR Part 11–compliant controls. Overview: teams need to map the tools to launch or run a study. Tool categories: consent, data capture, ePRO, enrollment, randomization. What teams actually need: one platform, full audit trail, documentation for validation. Capture fit: one platform for EDC, eConsent, ePRO; study builder; documentation for sponsor validation (Enterprise).
Overview and tool categories
The tools needed to run a trial include consent, data capture, ePRO, enrollment, and (when needed) randomization. What teams actually need is one platform with 21 CFR Part 11–compliant controls and documentation for sponsor validation.
Tool categories
- eConsent: version control, e-signature, one audit trail
- EDC: CRFs, visits, one audit trail
- ePRO: questionnaires, diaries, one audit trail
- Enrollment: screening, consent, one audit trail
- Randomization: allocation logged and auditable (when required)
What teams actually need
- One platform instead of multiple vendors
- Full audit trail and 21 CFR Part 11–compliant controls
- Documentation for sponsor validation when required
- Capture: one platform for EDC, eConsent, ePRO
Capture fit
- One platform for EDC, eConsent, ePRO; study builder
- 21 CFR Part 11–compliant controls and HIPAA-compliant security
- Documentation for sponsor validation (Enterprise); explore platform or book a demo
FAQ
Questions we hear a lot
What tools are needed to run a clinical trial?
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