PV Automation
Signal management automation for PV teams that cannot afford to miss a DDI signal in a polypharmacy regimen.
From FAERS ICSR ingestion through signal triage and PSUR data compilation — automated at each step, with an immutable audit trail ready for FDA/EMA inspection.
Automated PV Workflow
Five steps from raw ICSR corpus to PSMF-ready signal output
Data Ingestion
FAERS + EudraVigilance automated pull on quarterly FDA release cycle. Deduplication with prior corpus. Normalized to internal schema.
Saves: 8–12 hrs/quarter manual importCase Deduplication
AI-assisted ICSR deduplication removes follow-up reports and cross-database duplicates. Confidence score assigned per dedup decision.
Saves: 3–5 hrs/week on follow-up triageSignal Generation
Multi-drug graph analysis across cleaned corpus. N-drug combination IC scoring. Bayesian propagation identifies indirect interaction signals.
Detects: signals 60–120d earlier than RORSignal Triage
Signals ranked by clinical severity + reporting velocity. Auto-assigned to Monitor / Investigate / Escalate tiers. Reviewer queue generated with priority ordering.
Saves: 4–6 hrs/week manual prioritizationReporting
Structured output for PSMF/PSUR. MedDRA-coded signal summaries. Audit trail exported with each report. ICH E2E compliant format.
Saves: 10–16 hrs/PSUR cycle compilationICSR Processing
Individual Case Safety Report automation
Individual Case Safety Report processing is the most labor-intensive recurring task for PV teams — particularly during FAERS quarterly release windows when 200,000+ new reports arrive simultaneously. TrialVyx automates the initial classification layer, reducing time-to-triage from hours to minutes per case while routing ambiguous narratives to human review with structured context pre-populated.
ICSRs classified against CCSI/company core data sheet. Unexpected events flagged for priority human review. Seriousness criteria applied per ICH E2A.
AI-assisted PT code suggestion with confidence score. Complex or ambiguous narratives routed to human coder with context. Reduces coding time by estimated 60–70% on standard cases.
WHO-UMC causality criteria applied as a classification aid. Final causality assessment remains with qualified pharmacovigilance physician — the tool provides structured data, not the decision.
Processes FAERS quarterly releases of 200,000+ reports within 48 hours of availability. No queue backlog during high-volume regulatory submission periods.
ICSR processing time comparison
From generic pharmaceutical manufacturer case study. Results may vary.
Aggregate Reporting
PSUR / PBRER preparation support
Cumulative signal data compiled automatically
All signals from the reporting interval — detected, investigated, closed, or ongoing — compiled into a structured summary. ICSR volume by seriousness, expectedness, and reporter type. Tabular outputs formatted for direct import into aggregate report templates.
ICH E2ESection-by-section summary generation
Structured signal summaries generated for each compound in the PSUR interval — action taken, status at data lock, rationale documented with source ICSRs. Scientific judgment remains with your PV scientist; TrialVyx provides the structured data scaffold.
PSMF-readyICH E2E-compliant format
Output structured per ICH E2E guideline on pharmacovigilance planning. Direct compatibility with aggregate report templates used by FDA, EMA, and PMDA submissions.
Designed to feed existing templates
TrialVyx outputs integrate with your existing PSUR/PBRER templates — we do not replace your aggregate report authoring process, we feed it with structured, verified data.
Inspection Readiness
Audit trail designed before the algorithm
Every signal access, triage decision, and suppression is logged with timestamp and user ID. Every data source version used in each detection run is recorded. The audit trail is not an afterthought — it's the primary product constraint we designed around.
When your QA team asks for signal documentation during a mock inspection, the output is already formatted the way they need it. Export in FDA/EMA inspection-compatible format at any time, for any date range, for any signal.
Audit log sample entry
See how the workflow maps to your current signal management process.
Request a 30-minute walkthrough with your PV team. We'll go step by step through ICSR ingestion, signal triage, and PSUR output against your specific compound portfolio and regulatory obligations — not a generic demo.