Adverse event tracking, SAE management, and safety signal detection.
The Safety & Pharmacovigilance module provides comprehensive adverse event management from initial report through regulatory submission. Track SAEs, SUSARs, and AEs of special interest with causality assessment, severity grading, and seriousness determination. Safety signal detection algorithms analyze aggregate AE data to identify emerging safety concerns early.
Explore the module's workflow through interactive interface mockups showing each step of the process.
Capture adverse events with structured fields for event term, severity, causality, and outcome. MedDRA coding is applied automatically.
Track SAEs through the expedited reporting workflow with regulatory submission deadlines and status monitoring.
SAE-2024-001
Cardiac event — Site A
SAE-2024-002
Hepatic toxicity — Site C
SAE-2024-003
Anaphylaxis — Site B
SAE-2024-004
Severe anemia — Site D
SAE-2024-005
Stroke — Site E
Aggregate safety overview showing AE frequency by system organ class, severity distribution, and signal detection alerts.
Total AEs
847
across 1,248 subjects
Serious AEs
34
2.7% incidence
Signal Alerts
3
Investigating
Expedited Reports
12
On schedule
How Safety & Pharmacovigilance integrates with other CTMS modules in the platform.
AEs linked to specific enrolled subjects
Safety profile tracked at study level
Safety reports submitted via regulatory vault
Safety signals trigger central monitoring alerts
AI analyzes safety trends for recommendations
Safety profile impacts trial success prediction