Every clinical-trial event becomes an FDA-grade receipt — ALCOA+ compliant, signed twice, valid the day a regulator asks.

$200B+ global clinical-trial spend in 2026. Veeva Vault, Medidata Rave, Pfizer, Roche, and Novartis already have eTMF, EDC, and validation systems — none give them a post-quantum durability layer that survives a 15-year FDA inspection in 2041 when classical Ed25519 is broken. AgentGuard sits underneath them — every protocol amendment, every consent capture, every adverse-event report, every CRO data transfer, every database lock — captured as a dual-signed (Ed25519 + ML-DSA-65) receipt anchored to Base 8453, ALCOA+ compliant by construction.

The ROI on a single Phase III oncology trial

AgentGuard ingests events from any eTMF, EDC, CTMS, IRT, ePRO, or CRO data-transfer pipeline already in place. Every state transition becomes a dual-signed receipt with a chain pointer to its predecessor and the full ALCOA+ attribute set encoded as named fields. The numbers a Head of Data Integrity, a VP of Regulatory Affairs, or a CRO QA Director presents to the steering committee are these.

A sponsor running ten active Phase II/III programs with roughly 50,000 evaluable subjects spends on the order of $500K–$2M / year on AgentGuard receipts at the Sponsor tier — against a single Form 483 data-integrity finding that already costs an eight-figure remediation cycle and a six-month delay to approval. The unit math defends itself.

Receipt rail, not an EDC

EDC vendors hold the case-report-form data and validate against the protocol. eTMF vendors hold the trial master file documents. CTMS vendors hold the operational state. AgentGuard does none of those. It produces the cryptographically-anchored ALCOA+ receipt that proves a recorded clinical-trial event happened the way the sponsor says it did — from the protocol amendment that authorized it, through every consent, screening, dosing, adverse-event report, ePRO capture, and CRO transfer that touched it, to the database lock and FDA submission. That separation is the point.

Every sponsor, CRO, and academic medical center produces the same kind of evidence under different vendor names. The evidence is platform-neutral — that is what makes it defensible to an FDA inspector under 21 CFR Part 11, to an EMA inspector under Annex 11, or to an MHRA inspector with no network access in 2041.

How a Form 483 finding gets prevented in a 2031 FDA inspection

A specific, narrated example. A 2026 Phase III oncology trial enrolls patient #847 at a community oncology site. Five years later, in 2031, the FDA arrives for a pre-approval inspection. The inspector picks one subject at random and asks: prove this patient consented to the v3.2 protocol amendment that was active on the day of consent. The clock is the only thing that matters now.

Live verification — what an inspector sees

The envelope is CBOR-canonical and verifies offline against the issuer’s published public keys — no Hive call required at verification time. The panel below is the same shape every FDA, EMA, MHRA, or PMDA inspector renders, with the full ALCOA+ attribute grid encoded as named fields.

That panel is the entire product surface an FDA inspector or a 21 CFR Part 11 compliance officer needs. No demo. No login. The evidence is its own proof, and the proof works in fifteen years on a laptop with no internet.

Standards — what AgentGuard adds

Every existing clinical-trial standard answers a different question. AgentGuard does not replace any of them — it adds the cryptographic binding that makes each one defensible after the fact, including against quantum-capable adversaries in 2041.

3-step integration path

The 11 MCP tools

Eleven tools, all live in production. Contact for MCP integration credentials and the full well-known manifest.

The trial-event envelope

Every agentguard_*_attest call returns an envelope containing receipt id, trial id, event kind, subject (USUBJID + DID), investigator DID, AI agent DID where applicable, protocol version, IRB version hash, the full nine-field ALCOA+ attribute grid, prior-attestation id, Base 8453 anchor txid, and dual signatures (Ed25519 + ML-DSA-65). The signatures bind every field. Any tamper attempt invalidates verification.

The envelope is CBOR-canonical. Verification works offline against the issuer’s published public keys. ML-DSA-65 (NIST FIPS 204) is the post-quantum signature; Ed25519 (RFC 8032) provides classical assurance. Both must verify for the receipt to be valid. Receipts remain valid through key rotation via signed key history, so a 2026 consent is still defensible in a 2041 FDA inspection.

What this is not

Calibrated expectations are part of the product. AgentGuard is narrow on purpose.

Pricing

Per-event pricing fits adaptive Phase I and pilot programs. The $25K Site tier fits academic medical centers and community oncology networks. The $500K Sponsor tier fits mid-cap biotech and regional pharma. The $5M Big Pharma tier fits Pfizer, Roche, Novartis, Merck, AstraZeneca, J&J, Sanofi, GSK, and AbbVie portfolio scope and includes a 21 CFR Part 11 inspection-readiness affidavit on file. Settlement: USDC on Base 8453 via x402. Treasury 0x15184Bf50B3d3F52b60434f8942b7D52F2eB436E exists. Receipts settle in seconds; invoicing is monthly net-30 by default.

Field map

AgentGuard binds every clinical-trial lifecycle transition to a dual-signed receipt that drops cleanly into existing CDISC SDTM, HL7 FHIR R5, Veeva Vault API, and Medidata Rave API pipelines. Each call accepts the correlation fields below; the envelope round-trips through standard JSON / CBOR transports via the Hive Receipt primitive.

Cross with HiveComply when SOC 2, HIPAA, GxP, or EU AI Act audits are in scope — HiveComply ingests AgentGuard receipts natively. Cross with Atticus when a product-liability or DOJ False Claims Act case escalates to litigation.

Hive runs the receipt rail underneath the broader A2A · agent-to-agent commerce category.