Inspection — Stellis Vaccines (VAX-014)

Ingests protocol PDFs; produces structured analysis (population, endpoints, schedule of assessments).

Itemised study budgets, Medicare Coverage Analysis tagging, CTA redlines against negotiation playbook.

Continuous classification, naming, filing, and completeness checking of regulatory / eTMF documents.

Scores candidate sites against feasibility criteria and prior performance.

Scores site and population fit using RWD, EHR-derived counts, and prior enrollment performance.

Queries EHR / claims to estimate eligible population with per-criterion attrition funnel.

Analyses CTMS/EDC site performance metrics; produces a deterministic VisitPlan with for-cause overrides.

Fully deterministic study risk profiling by domain; produces StudyRiskProfile with escalation items.

Deterministic z-score statistics + LLM-generated narrative for signal explainability.

Deterministic site rankings and global quality index; model only for narrative summaries.

Maintains master timeline; models critical path; forecasts milestone slippage.

Drafts pre-reads, minutes, action trackers (A1); routine internal status (A3); sponsor-facing forces A2 + sign-off.

Runs and generates edit checks; detects discrepancies and deviations in incoming data.

Drafts, routes, tracks, and closes data queries — staged for CRA/DM review before site delivery.

Codes adverse events and medications to MedDRA/WHODrug with confidence scoring; low confidence escalates.

Maps raw study data to SDTM and derives ADaM datasets; double-mapping QC pattern for pivotal studies.

Drafts the statistical analysis plan from the protocol and endpoint definitions; assistive only.

Generates TLF code and outputs under double-programming verification; verificationPassed clamped to zero diffs.

Sample-size estimation, adaptive-design simulation, scenario modeling — assistive only.

Drafts protocols and amendments section-by-section per ICH M11 / E6(R3) / E8(R1).

Drafts ICH E3 CSR sections; every number traceable to a signed TLF; every claim cited.

Citation-grounded authoring support for clinical narratives; empty citedSources rejects output.

Generates EU CTR Annex V lay summaries; deterministic Flesch-Kincaid / Flesch Reading Ease gating.

Identifies and structures AE records from narrative source documents. NO causality field — architecturally enforced.

Deterministic ROR / PRR disproportionality analysis; LLM only for narrative context.

Drafts SUSAR narratives per ICH E2A; NO causality field; dual sign-off enforced before promotion.

Monitors audit trails across every system for anomalies, access violations, integrity issues.

Scores eTMF, deviation log, training records, and 5 other inspection domains; tracks CAPAs.

Detects protocol and GCP deviations from operational events; stages pending-classification for QA sign-off.

Answers any agent or human question against the corpus with cited sources; citation enforcement non-negotiable.

Continuously tests other agents against golden datasets; detects performance drift; triggers revalidation.

Surfaces and ranks new research opportunities (sponsors, indications, RFPs) from permissible sources; never contacts a sponsor or uses confidential intel.

Moves opportunities through sourced→qualified→bid→proposal→bid-defense→award with win-likelihood; pricing and award are always human acts.

Identifies likely-eligible candidates from de-identified/tokenized registries and runs a consent funnel; no PHI in staging, IRB-approved outreach only, clinician-confirmed eligibility.