Pharma / Life Sciences AI Reliability Snapshot

One AI system. Three days.
FDA + 21 CFR Part 11 readiness on a single page.

For pharma sponsors, biotechs, and CROs using AI in clinical-trial patient-eligibility screening, adverse-event detection, drug-discovery target selection, or manufacturing quality-control. FDA 21 CFR Part 11 electronic records + ICH E6(R3) GCP + FDA Diversity Plan Guidance + EMA AI Reflection Paper defensibility signal. Below-procurement-threshold pricing. Fixed $499, delivered as PDF via email within three business days.

$499/ 3-day turnaround
Buy the snapshot — $499
Direct-buy Stripe. No scope call required. Sub-corporate-card threshold.

See a sample Snapshot first

Before you spend $499, see exactly what you'll receive. Full sample $499 Snapshot report (synthetic-data example scenario) with all 8 sections, 3 charts, counterparty-question rehearsal, and signed determination:

See sample — free

The FDA + 21 CFR Part 11 question your AI can't answer

FDA Bioresearch Monitoring Program inspections + EMA scientific-advice reviews + DSMB safety-signal investigations now scrutinize AI-driven trial + safety decisions. FDA Draft Diversity Plans guidance imposes representative-population requirements enforceable via CRL. Question:

“Reproduce this AI-generated eligibility decision from [date] including patient's primary diagnosis, comorbidity profile at screening, inclusion/exclusion criteria state, model version, eligibility-score, and lane routed — as a defensible record we can produce for FDA inspection, EMA scientific advice, ICH E6(R3) essential-documents review, DSMB safety-signal investigation, or IRB continuing-review response.”

Most sponsors + CROs cannot reproduce AI-driven trial decisions with 21 CFR Part 11-compliant electronic-record precision. That gap risks CRL, trial re-run cost ($10M-$100M+ per program), and DSMB sanctions.

Vertical scope

AI Surfaces In Scope

  • Clinical-trial patient-eligibility AI
  • Adverse-event detection + PV AI
  • Drug-discovery target-selection AI
  • Manufacturing QC + release-testing AI
  • Real-world evidence + registry AI

Regulatory + Program Exposure

  • FDA CRL (Complete Response Letter) risk
  • FDA BIMO inspection finding
  • EMA scientific-advice conditions
  • DSMB safety-signal review + sanction
  • IRB continuing-review question + hold

What you get

Snapshot Report (1 page PDF)

  • Category A / B / C determination on the AI system
  • The-one-number: reproducibility-gap decision count
  • 21 CFR Part 11 + ICH E6(R3) + FDA Diversity Plan citations
  • Three specific fix-first items scoped to your surface
  • Sample sensor output + representative-population rehearsal

What it isn't

  • Full 8-layer AIC attestation (Enterprise at $35-55K)
  • GCP inspection remediation (advisory only)
  • FDA meeting prep or briefing document (separate)
  • Live re-audit or ongoing monitoring
  • Bespoke customization beyond snapshot template

How it works

1
Buy $499
Stripe direct, 60 sec
2
Intake form
5 fields + CSV upload
3
Analysis
Sensor runs 24-48 hr
4
PDF delivered
Day 3 via email

$499. Three business days. One signal your Head of Regulatory + CMO can act on.

If snapshot surfaces material FDA / EMA / DSMB exposure, upgrade path is $2,500 Baseline Audit (5 days), $15K Full Diagnostic (2-3 weeks), or $35-55K Enterprise Attestation (regulator-facing signed statement suitable for FDA advisory-committee submission). Snapshot credit applies to upgrade within 30 days.

$499 — buy now
Independent-verifier attestation. Not a legal / regulatory opinion. Scope limited to snapshot data submitted. Kept confidential under NDA on request. E&O carrier notified at Enterprise-tier engagement kickoff.