Nordic Pharmacovigilance Days is sponsored by AB Cube | SafetyEasy®
SafetyEasy® is AB Cube's modular, cloud-based platform for pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance.
Combining AI-supported intake, case management, regulatory reporting, literature monitoring and medical information, SafetyEasy helps organizations automate safety operations while maintaining control over workflows and regulatory requirements.
01 | Multivigilance Safety Database
Validated safety database for clinical and post-market case management, regulatory reporting and safety oversight.
- Automated E2B(R2/R3) reporting, regulatory gateways and partner exchange
- Customer-controlled workflows, reporting rules and user permissions
- Signal detection, safety analytics and compliance oversight
02 | AI-Supported Case Intake
Automated intake and case preparation with human oversight.
- Emails, documents, web forms, E2B files and partner reports
- AI extraction, translation, MedDRA coding and narrative generation
- Duplicate detection, triage and automated follow-up management
03 | Literature Management
Global and local literature surveillance with AI-assisted relevance screening, safety case identification and traceable review workflows.
04 | Medical Information Management
Omnichannel inquiry management with AI classification, approved response handling, adverse event detection and escalation into PV workflows.
Why SafetyEasy®?
- Modular & Connected: Deploy individual solutions or connect workflows across the safety lifecycle.
- Automation: From intake and case processing to follow-up and regulatory submissions.
- Customer Control: Configure workflows, reporting rules and permissions without vendor support.
- Validated & Flexible: GAMP 5-aligned validation framework, support for 21 CFR Part 11 requirements and transparent SaaS pricing.
