Pharma, biotech, and clinical research organisations run on validated systems and trial-grade data. 21 CFR Part 11, GAMP 5, ICH E6(R3), and the emerging AI-in-trials guidance turn every CI build and every model deployment into a regulator-visible artefact. Safeguard makes that artefact a signed pipeline output — not a year-long validation exercise.
E-signature, data integrity, AI-in-trials, and CRO oversight — all hitting one validated pipeline.
FDA expects electronic records and e-signatures with full traceability — who, what, when, why, and the audit trail behind it. Software that touches trial data inherits the same obligation as the records themselves.
Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, and Available. Any software in the trial data path has to demonstrably preserve those properties.
Draft guidance from the EMA and PMDA on AI in clinical research is converging fast. Lineage, validation, drift, and explainability are no longer optional — they have to be in the submission.
Sponsors run trials through a layered CRO ecosystem. Due diligence cannot stop at the prime contractor; sub-tier vendors carry the same trial data and the same regulator-visible risk.
SBOM emission, signing, retention, and querying run inside a GxP-validated CI pipeline. The pipeline itself ships with IQ / OQ / PQ evidence and a validation summary suitable for inspection.
Every AI model used in the trial workflow carries a signed lineage record — training data scope, training run hash, validation results, deployed version. Available to the regulator as an attestation, not a slide.
Continuous monitoring across prime CROs and their sub-tier vendors. Concentration risk, residency posture, and breach signals are visible at the sponsor level — not just at quarterly review meetings.
IND / NDA / MAA submissions increasingly require an AI bill of materials. Safeguard generates the AI-BOM from the same pipeline that emits the software SBOM — one source of truth, machine-readable.
Pre-mapped control narratives and evidence in the formats inspectors at CDER, CBER, EMA, and PMDA already accept.
GxP-validated CI pipeline, signed trial-AI provenance, multi-site evidence sync, and a CDER / CBER-ready trust packet.
CI / CD agents, signing infrastructure, and SBOM emission run inside a validated environment. Change control, IQ / OQ / PQ, and validation summary live with the pipeline.
Trial AI models — eligibility, adjudication, safety signal — carry signed lineage from training run to deployed version. SHA-pinned weights, signed model cards.
Sponsor sites and CROs across US, EU, and APAC share a common evidence store with per-region residency. Inspection-ready from any site, no email roundtrips.
Pre-mapped submission packet for FDA CDER / CBER, EMA, and PMDA. SBOM, AI-BOM, VEX, audit trail, and validation summary — exported in the formats the reviewer already accepts.
Eligibility, adjudication, and safety-signal models drift quietly as data distributions move. Drift inside a trial is a data-integrity event, not a software bug — and the inspector will treat it that way.
Prime CROs and sub-tier vendors hold trial data, eCRF systems, and randomisation services. A breach upstream becomes the sponsor's reportable incident and the sponsor's clock.
Submissions that reference AI-assisted analysis need a complete lineage record. A gap in lineage becomes an information request from the reviewer — and a delay to the program.
Sequencers, chromatography systems, and bench instruments run software that nobody patches between calibrations. The connected-lab surface is now part of the GxP perimeter.
Numbers from production deployments inside sponsors and CROs. Same inspector, same trial, dramatically less submission overhead.
| Metric | Before Safeguard | With Safeguard |
|---|---|---|
| 21 CFR Part 11 evidence prep | 8 weeks | 4 hours |
| Trial-AI lineage attestation prep | 3 weeks | 30 minutes |
| CRO continuous risk monitoring | 0% | 100% |
| Tool consolidation | 6 vendors | 1 |
| Submission AI-BOM prep | 2 weeks | 1 hour |
| Alert noise reduction | 75% | 5% |
| Vendor questionnaire turn-around | 14 days | 4 hours |
Talk to the team about GxP-validated SBOM pipelines, AI-BOM for submissions, and a CRO oversight posture that holds up under inspection.