SignalVault is an autonomous AI that monitors adverse events, detects safety signals, and files FDA/EMA reports — 24/7, without your team spending hours on manual case processing.
Every pharma company is required by law to monitor drug safety. But most mid-market teams are buried in manual intake forms, case processing, and report writing — chasing signals that surface too late and missing filing deadlines that cost millions in warning letters.
SignalVault ingests adverse event reports from all sources — EHR systems, patient portals, literature, social media. It triages by severity, detects emerging signals using medical NLP, generates causality assessments, and queues regulatory filings automatically.
Adverse events flow in from EHR integrations, web portals, literature, and direct reports. SignalVault normalizes and structures every case automatically.
Medical NLP scans every report in real time. Emerging signals surface before they become crises — and before regulators find them for you.
PSURs, RMPs, and signal narratives are drafted automatically in regulatory-ready format. Your team reviews and approves — doesn't write from scratch.
Every action is logged, time-stamped, and audit-ready. SignalVault maintains your compliance trail continuously — not just when an inspector shows up.
SignalVault is architected around FDA 21 CFR Part 11, EMA GVP modules, and ICH-E2D requirements from day one. Every signal detection is logged with full audit trail. Every AI-generated sentence is traceable to its source document.
SignalVault is built for mid-market pharmaceutical companies who need real pharmacovigilance — not a spreadsheet, not a legacy enterprise contract, and not a team of analysts manually chasing signals in the dark.