| Tier | ID | Signal | Category | Engine | Level | Wt | Adv |
|---|---|---|---|---|---|---|---|
| Participant | S-1042 | Candidate Hy’s-Law / DILI | Safety | On-device | red | 10 | |
| Participant | S-1042-ai | Free-energy surprise rising | Safety | On-device | amber | 6 | ADV |
| Participant | S-1039 | QTcF prolongation +48 ms | Safety | On-device | amber | 7 | |
| Participant | COH4-AE | Within-participant AE cluster | Safety | On-device | amber | 6 | |
| Participant | PK-EXP | PK exposure vs predicted Cmax | PK | On-device | green | 5 | |
| Participant | DLT-TALLY | Cohort DLT tally | Safety | On-device | green | 8 | |
| Participant | SAE-NEW | New unexpected SAE | Safety | On-device | green | 9 | |
| Study | SF-RATE | Screen-failure rate | Enrollment | Cloud | amber | 7 | |
| Study | LFT-DRIFT | Cohort-4 LFT distribution drift | Safety | On-device | amber | 6 | ADV |
| Study | ESC-33 | Cohort-4 escalation (3+3) | Dose-escalation | Cloud | green | 8 | |
| Study | QTL-SAE | Safety QTL (SAE rate) | Safety | Cloud | green | 8 | |
| Study | ENROLL | Enrollment rate vs plan | Enrollment | Cloud | amber | 5 | |
| Study | QRY-AGE | Open-query aging | Data | Cloud | amber | 4 | |
| Study | PROTDEV | Protocol-deviation rate | Compliance | Cloud | green | 5 | |
| Study | SITE-ACT | Site-activation lag | Operations | Cloud | green | 3 | |
| Client | AR-60 | Accounts-receivable aging > 60 days | Finance | Cloud | red | 9 | |
| Client | COMMS | Sponsor comms cadence | Relationship | Cloud | amber | 5 | ADV |
| Client | SCOPE-CO | Scope-reduction change-orders | Commercial | Cloud | amber | 6 | |
| Client | RENEWAL | Contract-renewal signal | Commercial | Cloud | green | 5 | |
| Client | FILINGS | Public-filings sentiment | Commercial | Cloud | green | 4 | |
| Client | SATIS | Sponsor-satisfaction pulse | Relationship | Cloud | green | 4 |
AI for Biometrics
Trial-Termination Early-Warning - Snapshot
Read-only shareable snapshot, computed from the signal feed signals.csv. The interactive tool is the Run & build the Shiny app page, and the visual guide explains the roll-up. The AI flags; the SRC / DSMB / medical monitor / PM / account lead decide. Synthetic, no PHI, no participant records.
35 · AMBER
Overall termination risk
38 · AMBER
Participant tier
24 · GREEN
Study tier
44 · AMBER
Client tier
All signals
Early-warning feed (firing, ranked)
Client · AR-60 Accounts-receivable aging > 60 days
payment-aging KRI breached
Participant · S-1042 Candidate Hy’s-Law / DILI
ALT 3.4x ULN + total bili 2.1x ULN (DLT window, day 9)
Client · COMMS Sponsor comms cadence ADV
-40% month-on-month - behavior drift, relationship watch
Client · SCOPE-CO Scope-reduction change-orders
2 this quarter
Participant · S-1042-ai Free-energy surprise rising ADV
active-inference EFE recommends an unscheduled LFT since day 7
Participant · S-1039 QTcF prolongation +48 ms
watch >30 ms, alert >60 ms
Participant · COH4-AE Within-participant AE cluster
cohort 4 trending Grade 2 to Grade 3
Study · SF-RATE Screen-failure rate
38% vs 25% plan - enrollment KRI breached
Study · LFT-DRIFT Cohort-4 LFT distribution drift ADV
Wasserstein tail mass moving up vs the pooled barycenter
Study · ENROLL Enrollment rate vs plan
-22% vs plan
Study · QRY-AGE Open-query aging
backlog rising ahead of database lock
The advanced-engine signals (marked ADV) use published methods: Optimal Transport / Wasserstein drift and Active Inference / free-energy. Reported safety numbers come from the validated safety database, never a model.