AI-MED TrialSafety
Agentic AI-Driven Safety Database for clinical trial safety management with three core functions
SAE Repository
Store SAEs/Case Narratives with automated data entry from SAE Forms.
Analytics Integration
Connect with GenAI‑OSCAR‑ML for safety analyses and reporting.
Regulatory Submission
Generate CIOMS/ICSR in ICH E2B(R3) XML for EudraVigilance.
FUNCTIONALITIES
SAE Data Capture & Repository
- Automated data extraction from SAE paper forms (OCR/ICR with GenAI validation)
- EDC integration via CDISC ODM format
- MedDRA coding with AI-assisted term suggestion
- WHO Drug Dictionary for concomitant medications
- Duplicate detection with configurable matching rules
- GenAI case narrative generation with mandatory human review
GenAI-OSCAR-ML Integration
- RESTful API for real-time safety signal detection
- Aggregate report generation: DSUR, PBRER/PSUR, Line Listing
- Dashboard with KPIs and safety metrics
ICSR/EudraVigilance Submission
-
ICH E2B(R3) XML generation (Schema v2.5)
-
CIOMS I PDF generation for legacy requirements
-
Automated XML validation before submission
All Our Services
GenAI-Driven Synthetic Control Arm
GenAI-Driven RWD Acquisition & Analysis
Target Trial Emulation for Drug Repurposing
Realistic and Privacy-guarantees Synthetic Patient Data
AI-MED Documenta
AI-MED eSource Hub
AI-MED TrialSafety
GenAI-Driven Remote Verbal Consent
CONTACT DETAILS
info@aimedtrial.com
+39 3482630229