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A biopharma trial-eligibility AI failed silently. This is the $499 Snapshot that found it.

Casual-glance overview here. Every deeper claim is a click away: full sample report, each cited regulation, every chart, every finding — and "how does this help me?" companion pages for each.

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The 4-number quick verdict

Determination

Category C

High-severity drift events

P3 exclude-lane rate

22% → 75%

Days to detect (silent)

45+

What does Category C actually mean? →

What happened in one paragraph

A mid-cap biopharma sponsor's AI trial-eligibility classifier silently over-routed P3 (age 65+, 3+ comorbidities, minority representation) to the ineligible_exclude lane. Aggregate enrollment-velocity + screen-fail-rate dashboards stayed green. The differential was visible only through per-patient-group distributional-shape analysis by an independent verifier. Under 21 CFR Part 11 + the FDA Diversity Plan Guidance + ICH E6(R3), every affected eligibility decision is now subject to preservation duty + representative-population review.

Read the full scenario walkthrough →

The three charts (each linked to its own deep-dive)

Chart 1 · Deep dive Rolling mean by patient group Where the silent P3 divergence begins. What the eye sees vs what the CTMS dashboard reported. Chart 2 · Deep dive Baseline vs recent distribution P3 mass moved RIGHT (into the ineligible_exclude lane). How to read the shape shift. Chart 3 · Deep dive Eligibility lane rate per patient group P3 ineligible_exclude rose sharply while other patient groups stayed stable. The pattern FDA + EMA look for.

Regulations applied — each on its own page

Every cited framework has a dedicated subpage with the actual regulatory text, plain-English translation, what the Snapshot shows against it, and a "how does this help me?" benefit companion.

Regulation 21 CFR Part 11 Electronic Records + Electronic Signatures. Preservation + reproducibility duty on every AI-driven eligibility decision. Regulation FDA Diversity Plans Guidance (Apr 2022) Representative-population enrollment. The rule the P3 exclude-lane differential triggers. Regulation FDA AI/ML SaMD Action Plan Good Machine Learning Practice + Total Product Lifecycle stance for AI used in trials. Regulation FDA PCCP Draft Guidance Predetermined Change Control Plan. Envelope of allowed AI-model modification + when drift breaks it. Regulation ICH E6(R3) GCP Good Clinical Practice. Essential-documents duty on AI-driven eligibility records. Regulation ICH E8(R1) + E9(R1) General considerations + statistical principles updates for AI-in-trials. Regulation EMA Reflection Paper on AI AI in the medicinal-product lifecycle. EMA scientific advice + MAA stance. Regulation 21st Century Cures Act Sec. 3013 Real-World Evidence + representative-population requirements. PMC-trigger risk. Regulation FDA CDER AI Framework Center for Excellence in Regulatory Decision Science. CDER's stance on AI in drug review. Regulation IRB Common Rule (45 CFR 46) IRB continuing-review of AI-driven eligibility decisions. Trial-site suspension risk. Regulation (shared) HIPAA 45 CFR 164 Privacy + Security + Breach Notification. Applies to AI training + inference on patient data. Regulation (shared) NIST AI RMF 1.0 GOVERN / MAP / MEASURE / MANAGE. Voluntary but load-bearing baseline.

Findings + methodology deep dives

Methodology How Category C is derived Category A / B / C decision logic. Why 10 high-severity events + P3 differential = C. Methodology Counterparty-question rehearsal The 5-decision reproducibility drill your Reg Affairs + BIMO-response counsel will thank you for. Methodology Independent-verifier declaration Why the control plane cannot reside within the sponsor / CRO / clinical-AI vendor being reviewed.

The full records

Full Snapshot Report (markdown) Executive One-Pager (markdown) Long-form single-page view

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

Same structure as this sample. Your sponsor's data, your AI system, your trial phase + indication, your FDA / EMA / ICH framework citations. Below procurement threshold. Report PDF via email.

Buy your Snapshot -- $499

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