Digital Tools for Clinical Research
Digital tools for clinical research: overview, tool categories, and what teams need. EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls.
21 CFR Part 11 compliant · HIPAA-compliant security · No credit card required
Overview
Digital Tools for Clinical Research
Digital tools for clinical research include EDC, eConsent, ePRO, randomization, and enrollment—in one platform with 21 CFR Part 11–compliant controls. Overview: teams need to map the software stack 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
Teams mapping digital tools need to understand tool categories: consent, data capture, ePRO, enrollment, 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 digital tools are needed for clinical research?
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