Kaia Pharma
Drug safety lifecycle intelligence from signal to post-market.
From initial safety signal detection through post-market surveillance, Kaia Pharma manages the complete pharmacovigilance lifecycle. Every expert correction makes adverse event detection measurably better.
Full Lifecycle
Every stage of drug safety, powered by intelligence.
Signal Detection
Adverse event signal detection from clinical trials, literature, and spontaneous reports.
Case Processing
Individual case safety report creation, medical assessment, and causality evaluation.
Regulatory Filing
Automated MedWatch/CIOMS form generation, expedited and periodic reporting.
Post-Market
Ongoing safety monitoring, risk management plans, and label updates.
Classification
Four categories. Patient safety first.
Adverse event reports, product recalls, patient death/injury — requires immediate pharmacovigilance escalation and 15-day expedited reporting.
FDA submissions, IND/NDA amendments, clinical trial protocols, GMP audit findings requiring compliance team review.
Routine manufacturing records, batch documentation, quality control results within spec. Normal processing workflow.
Breakthrough therapy designations, fast-track submissions, priority review documents requiring accelerated processing.
The Learning Loop
Every correction makes the system smarter.
AI Classifies
Upload a document. The Intelligence Engine analyzes it and returns a classification with confidence score and detailed reasoning.
Expert Corrects
Pharmacovigilance specialists review classifications. If the AI missed a safety signal, they correct it — critical corrections are escalated immediately.
System Learns
Each correction creates a training data pair. Safety-critical patterns get priority learning. Detection accuracy improves measurably every month.
Pharma Differentiator
15-day reporting compliance.
FDA requires expedited reporting of serious adverse events within 15 calendar days. Kaia Pharma ensures critical safety signals are never buried in routine document queues.
0.95
Highest Confidence Threshold
Patient safety demands the highest bar. Every classification below 0.95 triggers mandatory pharmacovigilance review.
GxP
Validated Environment
Built for GxP-compliant environments with 21 CFR Part 11 electronic signature readiness, complete audit trails, and change control.
ICH
Global Harmonization
Classification system aligned with ICH E2B(R3) individual case safety report standards for global pharmacovigilance reporting.
Explore Other Verticals
Same Intelligence Engine. Different industries.
See it work. Right now.
Classify a pharma document. Correct the AI. Watch the learning loop in real time.