Hub & Spoke Guide

Decentralized clinical trials

Verifiable consent, eCRF reconciliation, and IRT in distributed trial designs — architecture-first and regulation-aware.

21 CFR 11eConsentIRT

What’s inside

For clinical operations, data management, and trial tech leads

eConsent that is cryptographically witnessed and IRB-reviewable
Cross-site eCRF reconciliation without a central custodian
Sponsor-agnostic randomization and unblinding (IRT)
21 CFR Part 11 conformance for electronic records and signatures
Data integrity and audit trails in a decentralized design
A reference architecture for your next DCT

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