HiveALCOA turns every clinical trial event into an FDA-grade receipt. It's ALCOA+ compliant, signed twice, and still valid the day a regulator asks.

Clinical trials will cost over $200B worldwide in 2026. Veeva Vault, Medidata Rave, Pfizer, Roche, and Novartis already run eTMF, EDC, and validation systems. None of them give you a signature that still holds up at a 15-year FDA inspection in 2041, once today's Ed25519 signatures are breakable. AgentGuard sits underneath them. Every protocol amendment, every consent capture, every adverse event report, every CRO data transfer, and every database lock gets captured as a receipt signed twice (Ed25519 plus ML-DSA-65) and anchored to Base 8453. It's built to meet ALCOA+ from the ground up.

High-volume or negotiated terms? Talk to Steve

What this is worth on a single Phase III oncology trial

AgentGuard reads events from any eTMF, EDC, CTMS, IRT, ePRO, or CRO data-transfer pipeline you already have. Every state change becomes a receipt signed twice, with a pointer back to the event before it, and the full ALCOA+ attribute set written into named fields. Here are the numbers a Head of Data Integrity, a VP of Regulatory Affairs, or a CRO QA Director can bring to the steering committee.

A sponsor running ten active Phase II/III programs with about 50,000 evaluable subjects pays around $0.0192 per event. Compare that to a single Form 483 data integrity finding, which already costs an eight-figure fix and a six-month delay to approval. The math speaks for itself.

A receipt rail, not an EDC

EDC vendors hold the case report form data and check it against the protocol. eTMF vendors hold the trial master file documents. CTMS vendors hold the operational state. AgentGuard does none of that. It produces the signed ALCOA+ receipt that proves a recorded clinical trial event happened the way the sponsor says it did. That covers the protocol amendment that authorized it, every consent, screening, dosing, adverse event report, ePRO capture, and CRO transfer that touched it, all the way to the database lock and FDA submission. Keeping that separate is the whole point.

Every sponsor, CRO, and academic medical center produces the same kind of evidence, just under different vendor names. That evidence doesn't depend on any one platform, which is what makes it hold up to an FDA inspector under 21 CFR Part 11, to an EMA inspector under Annex 11, or to an MHRA inspector with no internet access in 2041.

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

Here's a specific example, walked through step by step. A 2026 Phase III oncology trial enrolls patient #847 at a community oncology site. Five years later, in 2031, the FDA shows up for a pre-approval inspection. The inspector picks one subject at random and asks the sponsor to prove this patient consented to the v3.2 protocol amendment that was active on the day of consent. Now the clock is the only thing that matters.

Live verification: what an inspector sees

The envelope is CBOR-canonical, and it checks out offline against the issuer's published public keys. No call to Hive is needed to verify it. The panel below is the same one every FDA, EMA, MHRA, or PMDA inspector sees, with the full ALCOA+ attribute grid written out as named fields.

That panel is everything an FDA inspector or a 21 CFR Part 11 compliance officer needs. No demo, no login. The evidence proves itself, and it still works fifteen years from now on a laptop with no internet.

Standards: what AgentGuard adds

Every existing clinical trial standard answers a different question. AgentGuard doesn't replace any of them. It adds the signature that makes each one stand up after the fact, even against quantum computers in 2041.

3-step integration path

The 11 MCP tools

All eleven tools are live in production. Contact us for MCP integration credentials and the full well-known manifest.

The trial event envelope

Every agentguard_*_attest call returns an envelope with the receipt id, trial id, event kind, subject (USUBJID plus DID), investigator DID, AI agent DID where it applies, protocol version, IRB version hash, the full nine-field ALCOA+ attribute grid, the prior attestation id, the Base 8453 anchor txid, and two signatures (Ed25519 and ML-DSA-65). The signatures cover every field, so any attempt to tamper with it breaks verification.

The envelope is CBOR-canonical, and you can verify it offline against the issuer's published public keys. ML-DSA-65 (NIST FIPS 204, the government's post-quantum signature standard) is the post-quantum signature. Ed25519 (RFC 8032) gives you classical assurance on top. Both have to check out for the receipt to be valid. Receipts stay valid through key rotation using a signed key history, so a 2026 consent still holds up in a 2041 FDA inspection.

What this is not

Setting the right expectations is part of the product. AgentGuard is narrow on purpose.

Pricing

Per-event pricing at $0.0192 / event fits any trial scale, from adaptive Phase I pilots to global Phase III programs. Volume-commit accounts bundle events at the same rate with monthly invoicing. You settle in USDC on Base 8453 through x402. Treasury address 0x15184Bf50B3d3F52b60434f8942b7D52F2eB436E exists. Receipts settle in seconds. Invoicing is monthly, net-30 by default.

Field map

AgentGuard signs every clinical trial lifecycle change twice, and it 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 travels through standard JSON / CBOR transports using the Hive Receipt primitive.

Pair this with HiveComply when SOC 2, HIPAA, GxP, or EU AI Act audits are in scope. HiveComply reads AgentGuard receipts natively. Pair it with Atticus when a product liability or DOJ False Claims Act case turns into litigation.

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