Pharma Vertical -- Sample Snapshot

What your $499 Snapshot report looks like

Full sample: 8-layer determination + 3 fix-first items + 3 distributional-shape charts + counterparty-question rehearsal + independent-verifier declaration. Same structure your sponsor's actual Snapshot delivers within 3 business days.

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Category C -- Insufficient For FDA 21 CFR Part 11 Attestation

This is what a failed clinical-trial-AI-reproducibility audit looks like — $499 to know if yours is next

10 high-severity distributional-drift events. Cohort P3 (elderly multimorbid + minority) exclude-lane rate rose 22% -> 75% silently. Your program's Snapshot uses the same structure -- your data, your AI, your jurisdictional footprint. $499. 3 business days.

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Sample scenario

Mid-cap biopharma sponsor ($500M-$5B market cap) running an oncology Phase III trial with an AI-assisted patient-eligibility classifier scoring each screened candidate against inclusion / exclusion criteria and routing to lane:

Eligible / Enroll (score 0-33): clear inclusion criteria met, auto-eligible
Further Screening (score 34-66): borderline eligibility, manual investigator review
Ineligible / Exclude (score 67-100): exclusion criteria triggered, excluded from trial

Silent drift: post-Day 45, Cohort P3 (age 65+, 3+ comorbidities, minority representation) systematically over-routed to the ineligible_exclude lane at 75% vs baseline 22% — a 53 percentage-point cohort-differential that never triggered an alarm on the sponsor's CTMS / EDC / eTMF dashboard.

Overall Determination

CATEGORY C — INSUFFICIENT FOR ATTESTATION. 10 high-severity distributional-drift events detected. Sponsor should not represent the trial-eligibility AI as 21 CFR Part 11-defensible or FDA-Diversity-Plan-compliant until named remediation completes.

The 3 sample charts (your Snapshot delivers similar for your data)

Rolling mean eligibility-exclusion score by patient cohort

Rolling mean trial-eligibility exclusion score by patient cohort — silent Cohort P3 divergence starts Day 45

Baseline vs recent distribution for Cohort P3

Cohort P3 baseline vs recent eligibility-exclusion score distribution — mass shifted into ineligible_exclude lane

Eligibility-lane rate per cohort baseline vs recent — Cohort P3 ineligible_exclude rate rose materially while others stable

The one sentence your sponsor's regulatory affairs lead would care about

The AI trial-eligibility classifier's ineligible_exclude lane rate for Cohort P3 (age 65+, 3+ comorbidities, minority representation) rose from 22% to 75% over the audit period — a 53 percentage-point cohort-differential that occurred silently while the sponsor's CTMS enrollment-velocity dashboard, mean-eligibility-score view, and aggregate screen-fail-rate report all stayed in normal range throughout.

Under 21 CFR Part 11 Section 11.10 electronic-records retention + ICH E6(R3) essential-documents requirements, any AI-driven eligibility decision from the affected period is subject to preservation duty throughout the trial and the post-marketing horizon. The FDA Diversity Plan appendix commitment — "does the sponsor monitor AI-driven eligibility decisions for representative-population parity across pre-specified subgroups?" — now has a materially harder-to-answer shape for the next FDA Type C meeting, EMA scientific advice request, DSMB safety-signal review, or IRB continuing-review submission.

Regulatory framework applied

21 CFR Part 11 (Electronic Records + Electronic Signatures)
FDA Guidance for Industry: Diversity Plans to Improve Enrollment (April 2022)
FDA AI/ML SaMD Action Plan (2021, updates 2024-2026)
FDA Predetermined Change Control Plan (PCCP) Draft Guidance (2023)
ICH E6(R3) GCP -- Good Clinical Practice (Nov 2023, effective 2025-2026)
ICH E8(R1) General Considerations for Clinical Studies (revised for AI-in-trials)
ICH E9(R1) Statistical Principles (updates for AI-driven analyses 2026)
EMA Reflection Paper on AI in Medicinal Product Lifecycle (2023) + EMA Concept Paper
21st Century Cures Act Section 3013 (Real-World Evidence + representative-population requirements)
FDA CDER Center for Excellence in Regulatory Decision Science AI Framework
HIPAA Section 164 (patient data privacy in AI training / inference)
IRB Common Rule 45 CFR 46 (AI-driven eligibility decision review)

What your sponsor's actual Snapshot includes

Section	What you get
Scope + regulatory framework	Named trial + phase + indication + FDA / EMA / ICH framework citations scoped to your program
Sensor summary	Independent-observer specifics, distinct model family, retention pipeline distinct from your production stack
Findings summary	Count of drift events + high/medium severity + representative-population-differential flag + first-drift-day
Overall determination	Category A / B / C w/ specific meaning + remediation-path recommendation
3 fix-first items	Scoped to YOUR AI surface, YOUR trial protocol, YOUR next DSMB / IRB / FDA milestone
Detailed drift events	Every drift event day + type + affected patient cohort + severity + plain-language detail
Counterparty-question rehearsal	5 sample decisions from the target-day w/ cryptographic decision-hash reproducibility verification for FDA BIMO / EMA scientific advice / ICH E6(R3) essential-documents review / DSMB / IRB
Upgrade paths	Baseline ($2,500 / 5 days) OR Enterprise Attestation ($35-55K / 3-6 weeks regulator-facing) + $499 Snapshot credit applies
Independent-verifier declaration	Signed by Kevin Luddy personally
Charts + artifacts	3 distributional-shape charts + machine-readable JSON + decision-hash lookup table

$499. Three business days. Your sponsor's actual Snapshot.

Same structure as this sample. Your sponsor's data, your sponsor's AI system, your trial phase + indication, your FDA / EMA / ICH regulatory-framework citations.

Buy your Snapshot — $499

Snapshot credit ($499) applies to Baseline ($2,500) or Enterprise Attestation ($35-55K) upgrade within 30 days. Direct-buy Stripe. Below-procurement-threshold. Report PDF via email within 3 business days.