Benefit — reproducibility discipline
What the 5-decision drill actually saves you
Reproducibility discipline is the single largest lever in BIMO response cost + inspector negotiation stance + plaintiff-discovery stance. The 5-decision Snapshot rehearsal is the low-cost proof that the discipline is operational.
The three cost buckets it addresses
- BIMO / inspection response cost. Reproducing named decisions on request when the retention discipline is not in place = 10-100x the cost of reproducing when the discipline was already in place. Reactive-response cost stacks with each successive request.
- Adverse-inference / Form 483 risk. Inspectors and courts can escalate when a sponsor fails to produce records that should exist. AI-decision records fall squarely in that risk profile.
- Expert-witness credibility. The sponsor's expert witness's testimony carries different weight depending on whether the sponsor's own retention discipline was demonstrably in place at the time of the events.
Dollar frame
BIMO reproduction-request gap cost: reactive AI-decision-record production for a named-inspection request typically runs $250K-$1M in Reg Affairs + vendor-forensics + external counsel time. Proactive discipline compresses that to weeks-of-effort inside existing Clinical Operations.
Plaintiff-discovery cost gap: $150K-$500K per matter for reactive reproduction. Class-action exposure much larger.
Snapshot proof cost: $499. Same 5-decision drill on your actual trial-AI surface.
What "5 decisions" actually proves
If 5 decisions can be reproduced defensibly on a randomly-selected target day, then the retention pipeline works structurally. That structural claim is what matters — not those 5 decisions themselves.
The rehearsal is a discipline test, not a discovery response. When a discovery response is later required, the pipeline that reproduced 5 can reproduce 500 — the marginal cost is bounded and predictable.
What "having it" looks like
Green: BIMO / subpoena lands for AI-decision records tied to a specific screening. Reg Affairs runs the same reproduction procedure the Snapshot rehearsed. Records produced in the requested window. Matter proceeds on merits, not on records-production gaps.
Red: Request lands. Clinical-AI vendor's decision trace rotated with the model. Reproduction requires forensic reconstruction. Cost escalates. Form 483 or adverse-inference risk becomes live.
Who at your org cares
- VP Regulatory Affairs — BIMO + inspection response readiness
- General Counsel — discovery-defense + adverse-inference risk
- Chief Quality Officer — retention-pipeline SOP
- Head of AI/ML Governance — retention-pipeline operational reality
- Chief Risk Officer — reserve implications
$499. 3 business days.
The proof your retention discipline works — produced now, referenced whenever needed.
Buy $499