◈ S-EXT Statutory & Wet-Evidence Bridge

Zero-Physical-Custody External CRO Drop-Shipping Protocol

Legally acquires authentic wet-lab IC50, CoA mass-spec purity, and rodent PK evidence with ZERO physical laboratory or reagent handling license by dispatching compounds directly from synthesis vendor to ISO-17025 / GLP CROs and recomputing raw instrument wells independently.

Interactive CRO Raw Plate 4PL & Oral PK Recomputation + Tamper-Block Simulator

✓ G3 PASS

Zero-Physical-Custody Legal & Operational Architecture

sponsorPhysicalCustody = False

Sponsor (RISCON Labs) holds ZERO wet laboratory, animal facility, or chemical/biological reagent inventory.
Custom synthesis vendor dispatches blinded solid/DMSO aliquots directly to an ISO/IEC 17025 or MFDS/OECD-GLP external CRO.
Sponsor receives ONLY machine-readable raw instrument outputs (.json/.csv plate RFU, LC-MS/MS chromatograms, PK plasma tables, signed CoA PDFs).
Before Phase I human IND filing, pivotal safety pharmacology & GLP toxicology studies must be executed at an MFDS-designated Non-Clinical GLP institution.

PYTHONPATH=. python3 -m cro_bridge.orchestrate && PYTHONPATH=. python3 -m cro_bridge.audit

Non-Employed Clinical Specialist (M.D. / MPH / Medical AI) Statutory & COI Governance

M.D. / IRB / COI

High-Impact Statutory Roles Enabled Without Employment

CLIN-1 · MFDS SaMD Clinical Evaluation & Intended-Use Framing✓ Permitted
Formal Clinical Advisory Agreement (자문위촉계약) enables clinical target framing, risk-benefit justification (ISO 14971), and reference-standard adjudication protocols without full-time employment.
디지털의료제품법 / 의료기기법 인공지능 의료기기 허가·심사 가이드라인
CLIN-2 · IEC 62366-1 Usability Engineering (Formative & Summative Representative Clinician)✓ Permitted
Board-certified OB/GYN & hospital director qualifies as an authentic target clinician user for formative/summative UI hazard walkthroughs (alarm fatigue, wrong-site/acidemia alert clarity).
IEC 62366-1:2015+AMD1:2020 / 식약처 의료기기 사용적합성 적용 가이드라인
CLIN-3 · Institution-to-Institution Collaborative R&D / Retrospective IRB Site✓ Permitted
Contracting with the medical institution (hospital) as a joint R&D or IRB clinical validation site unlocks the final 8–15 points of KHIDI TRL 5 clinical adoption.
생명윤리 및 안전에 관한 법률 / 보건의료데이터 활용 가이드라인

Mandatory COI & Statutory Guardrails (4th-Degree Kin & Pivotal PI Separation)

COI-1 · National R&D Innovation Act — 4th-Degree Relative (Cousin) Prior Disclosure & Approval✕ CRITICAL
Under Korean Civil Law Art. 777 & National R&D Innovation Act accounting rules, a first cousin (4촌 혈족) is a related party. Paid advisory fees or sub-contracts using government grant funds require prior written disclosure to the specialized agency (KHIDI IRIS); unpaid pro-bono advisory or independent institutional IRB collaboration avoids personal related-party disbursement.
COI-2 · MFDS Pivotal Clinical Trial Principal Investigator (PI) Recusal & Multi-Center Independence✕ CRITICAL
Pivotal confirmatory clinical trials for MFDS approval must run at an MFDS-designated Clinical Trial Institution (임상시험실시기관), and close-relative status with the sponsor CEO must be disclosed to the IRB (best practice: engage cousin's hospital for formative/retrospective R&D while assigning pivotal PI to an independent university hospital).
COI-3 · Quality Management Representative (품질책임자) Cannot Be Substituted by External Unaffiliated Advisor◈ HIGH
Under Medical Devices Act Art. 6-2, the statutory Quality Manager (품질책임자) for a licensed manufacturer must be an actual employee of RISCON Labs (can be satisfied upon commercial manufacturing license filing, not required during TRL 3–5 R&D).