Three months before the disproportionality analysis flags it, your safety team can already know.
TrialVyx applies N-drug graph analysis across 2 million FAERS adverse-event reports to surface polypharmacy DDI signals your standard ROR/PRR methods cannot detect — while there's still a window to act on them.
ROR and PRR are retrospective tools. By the time they flag, the window for action has passed.
Traditional signal detection methods — ROR, PRR, BCPNN — require adverse event accumulation before statistical significance emerges. In multi-drug regimens, that accumulation can take 18–24 months.
TrialVyx applies multi-source graph analysis across the full FAERS corpus plus co-prescription patterns to surface DDI signals 60–120 days earlier.
How It Works
Three steps from raw FAERS corpus to MedDRA-coded signal brief
Unified ICSR corpus
FAERS, EudraVigilance, and VigiBase ICSRs normalized into a single adverse event corpus. Duplicate follow-up reports identified and resolved before analysis.
2M+ reports / 180-day refreshMulti-drug graph analysis
Graph-based detection identifies N-drug interaction signals standard pairwise ROR/PRR analysis cannot find.
N-drug interaction graph, N≥2Triage and PSMF-ready output
Signals ranked by IC score, clinical severity, and 90-day reporting velocity. MedDRA PT and SMQ coded output structured for direct use in PSMF signal assessment records.
MedDRA SMQ + WHO-ART mappedSignal Intelligence
What you get: signal intelligence, not noise
Multi-drug interaction detection beyond pairwise analysis
Standard pharmacovigilance tools examine drug pairs. TrialVyx constructs N-drug interaction graphs — capturing triad and tetrad signals that pairwise ROR systematically misses in polypharmacy regimens.
N ≥ 2 drugs91-day median signal lead time in FAERS validation
Retrospective analysis against 312 historically confirmed FAERS drug interaction signals from 2019–2022. TrialVyx identified the same signals a median of 91 days before traditional methods would have flagged them.
91 daysRegulatory-audit trail for each signal
Every detection event logged with timestamp, data sources, contributing ICSRs, and methodology version. Inspection-ready export format.
MedDRA + WHO-ART coded output for your PSMF
Signal output includes MedDRA SMQ mapping and WHO-ART coding — structured for direct integration into your Pharmacovigilance System Master File.
Signal validation evidence from the FAERS historical record
We validate TrialVyx's detection methodology against the historical FAERS record — not synthetic benchmarks. Retrospective analysis across a corpus of confirmed post-market drug interaction signals provides an honest measure of detection performance.
Sensitivity and lead time figures are reproducible: if you have a historical confirmed signal corpus from your portfolio, we can run the same analysis for your compounds.
Numbers derived from retrospective analysis of 2019–2022 confirmed FAERS drug interaction signals. Internal analysis. Results may vary for specific compound portfolios.
From PV Teams
From pharmacovigilance teams
"We ran TrialVyx's retrospective methodology against two years of our cardiovascular portfolio. It flagged a CYP3A4-burden triad signal we had eventually caught through standard PRR — but 78 days earlier. That lead time changes whether you're preparing for a REMS decision or reacting to one."
Mid-size specialty pharmaceutical company, cardiovascular portfolio
"The signal audit trail was what our QA team needed and couldn't get from our existing FAERS query workflow. Every detection event — data source version, ICSR references, IC score, method version — documented in one place. During our mock inspection walkthrough it was the only thing our auditor didn't ask a follow-up question about."
Generic pharmaceutical manufacturer, oncology supportive care
Your PV team deserves a three-month head start.
TrialVyx is in early access. We work directly with safety teams to configure signal detection for your compound portfolio.
Talk to the team — [email protected]