概要
SIPO DRepレビュー支援用の日本語作業訳です。正式な内容はHydra Voting上の英語原文を参照してください。
この提案は、AxellaCoin / Axella Researchが運営する臨床研究OS EcoseraをCardanoと接続し、Aiken stablecoin patient stipend escrow、RWD/document provenance anchoring、AXC settlement adapter、FDA-aligned sponsor pilot、MLabs audit/legal/PM、Libertum/ResearchDAO連携を構築するものです。臨床研究は21 CFR Part 11、FHIR R4、RWE、IRB、FDA RTCTなどの監査・規制要件が強い高価値産業であり、SIPOとしてはCardanoの実産業利用・RWA/DeSci・規制産業インフラへの展開可能性を評価します。一方で、EOM Pharmaceuticals pilotの拘束力、AXCを用いた収益・決済モデルの規制性と実需、10% platform-fee revenue shareの法的強制力、Libertum/ResearchDAOとの依存と重複、患者データ/HIPAA/PHIの範囲、stablecoin stipendの運用、on-chain KPIの検証、未達時の返還を確認する必要があります。
英語原文を表示
Cardano's 2030 Vision calls for the network to power mission-critical applications for the economies of the future. Clinical research is one of the most mission-critical industries that exists — every approved drug depends on infrastructure that is auditable, tamper-evident, and regulator-grade. No public blockchain has established a credible foothold in this vertical. Ecosera is a live clinical research OS: EDC, eTMF (21 CFR Part 11), PHR (FHIR R4), RWE ingestion, IRB workflows, and patient-trial matching across 193 data models. Ecosera aligns with the FDA's real-world evidence and digital health frameworks, including the RTCT initiative, targeting compliant pilot programs through EOM Pharmaceuticals. It connects all stakeholders — sponsors, CROs, patients, regulators, and investors — in one verifiable ecosystem. This proposal funds six components: (1) Aiken stablecoin patient stipend escrow, (2) RWD/document provenance anchoring to Cardano, (3) parameterized stablecoin settlement adapter, (4) FDA-aligned sponsor pilot integration, (5) cross-cutting audit/legal/PM, and (6) an ecosystem integration layer connecting Ecosera with Libertum's RWA tokenization and ResearchDAO governance — enabling on-chain funding of clinical trials from inception through approval. All deliverables are Apache 2.0. Cardano alignment: Ecosera's recurring platform fees are denominated and settled in AxellaCoin (AXC), a native Cardano token. Every sponsor contract, site onboarding, document anchoring, and patient stipend disbursement generates AXC transactions on Cardano — creating a continuous, self-sustaining stream of real economic activity on-chain. This is not a one-time grant return: it is a permanent engine of Cardano transaction volume, MAU growth, and native token utility, driven by a regulated, revenue-generating platform operating in a $80B global industry.