1
Stage 1 PILSovereign Identity Layer
Sovereign DIDs for research subjects, investigators, and institutions enabling portable, privacy-preserving research identity across international collaborations.
2
Stage 2 CELImmutable Ledger
Immutable research data ledger for protocol deviations, adverse events, and outcome data with FDA 21 CFR Part 11-compliant cross-institutional audit trails.
3
Stage 3 AI GovernanceAutomated Compliance
Automated FDA, EMA, and ICH-GCP compliance mapping with AI-driven protocol deviation detection, regulatory reporting, and international research compliance.
4
Stage 4 Sovereign WalletsCredential Custody
Subject-controlled research participation credentials enabling portable consent management across multi-site and multi-institutional studies.
5
Stage 5 ZKPGZero-Knowledge Proofs
Zero-knowledge proof of execution for proprietary experimental data and regulatory submission without exposing raw subject data or institutional IP.