SafetyEasy® Suite by AB Cube is a comprehensive, cloud-based multivigilance management solution designed to streamline global safety operations and ensure regulatory compliance across multiple product types.
As a pioneer of SaaS vigilance applications since 2006, the platform offers a unified database for pharmacovigilance (PV), medical device vigilance (Materiovigilance), cosmetovigilance (CosmEthics®), and nutrivigilance, allowing for the management of complex cases like combination product reporting within a single application.
Key Features & Capabilities:
- AI-Powered Automation: The AB Cube Galaxy modules, including CasEasy AI (Natural Language Processing for case creation) and Converter (OCR for form data extraction), reduce manual effort and accelerate case intake by up to 70%.
- Regulatory Compliance: The system is fully compliant with global standards, including ICH E2B (R3), FDA 21 CFR Part 11, and GAMP 5, with automatic system updates to stay current with the latest regulations.
- Accelerated Reporting: Features like the Reportability Matrix and one-click submission through a dedicated gateway streamline the generation and submission of regulatory reports (e.g., CIOMS I, MedWatch, PBRER, PSUR).
- Data Management: Includes inbuilt MedDRA and WHO Drug Dictionary (WHODD) coding, signal detection modules (PPR, ROR, Qualitative), and a customizable workflow.
Target Users & Benefits: SafetyEasy® Suite is utilized by Marketing Authorization Holders (MAHs), pharmaceutical laboratories, Contract Research Organizations (CROs), and health authorities worldwide. It is positioned as a cost-effective, agile, and fully validated solution that offers lightning-quick data migration and a typical 'go-live' time of two weeks.