All use cases
Pharma & Clinical Trials
An AI model screens candidates for a clinical trial. A regulator asks the sponsor to justify every inclusion and exclusion, each call is sealed and unaltered.
The situation
A trial sponsor uses an AI model to screen candidates for eligibility. During inspection, the regulator requires the sponsor to evidence why each candidate was included or excluded, that the model's reasoning is recorded and the record has not changed since. Aegis Trace seals each screening decision with its inputs and rationale, so the sponsor produces a complete, inspection-ready trail.
The regulations
- EMA
- ICH GCP
- MHRA
- FDA 21 CFR Part 11
- GDPR
The evidence
Each eligibility decision is sealed with its rationale.
POST /v1/decisions
{
"decision": "exclude_candidate",
"regime": "ICH_GCP",
"criteria": ["prior_therapy", "renal_function"],
"redaction": "subject_id_tokenized"
}An inspection-ready certificate per screening call.
{
"certificate_id": "crt_ct_3b08",
"status": "sealed",
"decision": "exclude_candidate",
"regime": "ICH_GCP",
"issued_at": "2026-03-14T09:21:07Z",
"inputs_hash": "sha256:3f8a…c1d2",
"model": { "name": "decision-engine", "version": "4.2.1" },
"signature": {
"alg": "ed25519",
"value": "MEUCIQD…Qz9w",
"anchored": "rfc3161"
}
}What the regulator receives
A sealed certificate for every inclusion and exclusion decision, the criteria applied, with subject identifiers redacted, and proof the record was never altered after screening.