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.
Built for Your Role
What Kaia Pharma does for you.
Every role gets a purpose-built operating surface. Not a generic dashboard — a workspace designed for how you actually work in Pharma.
Detect safety signals 40% faster than manual surveillance
Aggregate view of adverse event classification, PADER/PSUR deadlines, and regulatory risk.
AI-powered causality assessment for every adverse event
Review pre-classified cases with evidence summaries. Focus on the signals that matter.
Automate 70% of routine case processing
Track regulatory submissions, IND/NDA timelines, and case processing throughput.
21 CFR Part 11 compliant with validated electronic signatures
Full GxP audit trail. AE classification accuracy tracked and reportable.
After signup, you choose your role and land directly in your Kaia Pharma workspace.
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.
Same Intelligence Engine · 8 Regulated Industries
See it work. Right now.
Classify a pharma document. Correct the AI. Watch the learning loop in real time.
Kaia Pharma Workflow
7-Stage Industry Process
Only pharmacovigilance platform publishing signal detection sensitivity, AE classification accuracy, and MedDRA coding accuracy. Veeva keeps all accuracy metrics secret. Every medical officer correction improves the model for all sponsors.
Signal Detection
Automated disproportionality analysis (PRR, ROR, MGPS), literature monitoring, FAERS/EudraVigilance mining
ICH E2E — pharmacovigilance planning
Case Processing
ICSR intake, MedDRA coding, narrative generation, duplicate detection, causality assessment
ICH E2B(R3) — electronic ICSR transmission standard
Regulatory Submission
IND safety reports (7/15-day), PSUR/PBRER generation, agency-specific formatting (FDA/EMA/PMDA)
21 CFR Part 11 — electronic records and signatures
Post-Market Surveillance
Ongoing benefit-risk assessment, REMS monitoring, label change intelligence, real-world evidence
FDA AI Credibility — algorithmic transparency requirements
Quality Management
CAPA tracking, deviation management, change control, inspection readiness
GxP Validation — computerized system validation
Audit & Compliance
Audit trail generation, ALCOA+ data integrity, regulatory inspection preparation
Model Governance
AI model validation, version control, performance monitoring, change documentation for regulatory compliance
EU AI Act — high-risk AI system requirements
Transparent Benchmark
Signal Detection Sensitivity
Target: 97% | Industry average: 88%
No competitor in Pharma publishes this data.