SafetyEasy
Efficient drug safety operations with the technological expertise of industry veterans begins here.
Align international pharmacovigilance operations teams with an intuitive, unified, cloud-based safety system trusted by industry leaders. SafetyEasy® Suite is a multivigilance management solution which integrates automation with existing drug safety processes.
Growing biotechnology firms trust individual vigilances provided by AB Cube for their safety regulatory processes. Life sciences organisations manage adverse event reporting and stay compliant with the latest regulations with SafetyEasy® Suite.
SafetyEasy® Suite is AB Cube’s all-in-one ecosystem for automated multivigilance management. Built to make safety simple, scalable, and smart. Designed for organizations of all sizes, it’s a modular, cloud-based platform that automates every step of the vigilance process, from early stage data capture to regulatory reporting and advanced analytics.
Flexible and compliant by design,
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Redica
Redica is an intelligence cloud platform designed to support quality and regulatory teams within life sciences organizations. It transforms complex global regulatory data into clear, actionable intelligence that helps teams stay compliant and proactive. The platform unifies regulatory intelligence, inspection findings, and supplier quality insights into a single connected system. By using explainable AI, Redica enables teams to monitor regulatory changes and understand their impact faster. Its inspection intelligence tools help organizations predict and prepare for audits using global benchmarking data. Redica also provides site and supplier intelligence to manage manufacturing and supply chain risks effectively. Overall, the platform shifts teams away from manual data tracking toward faster, insight-driven compliance decisions.
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Ennov Pharmacovigilance Suite
Ennov's Pharmacovigilance Suite is an end-to-end solution for collecting, managing, assessing, and reporting human and veterinary adverse events within a unified database. The suite offers advanced signal detection and data analysis tools, ensuring compliance with global regulatory requirements. Key features include efficient case intake and triage with optimized user interfaces for data entry, flexible case input forms, and searchable vocabulary lists. The system supports both paper and electronic reporting formats, including CIOMS, MedWatch 3500s, and ICH E2B standards (R2 and R3 formats). For signal detection and management, it provides comprehensive data querying, powerful analysis capabilities, and the calculation of key statistical measures such as PRR, ROR, and MGPS. The platform is 100% web-based, user-friendly, and designed to comply with 21 CFR Part 11, ensuring data integrity and security.
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Veeva Vault Safety
Veeva Vault Safety is a modern individual case safety report management system that supports the intake, processing, and submission of adverse events for clinical and post-marketed products. Within one system, sponsors and CROs can process global and domestic adverse events for drugs, biologics, vaccines, devices, and combination products. Built-in gateway connections and reporting rules streamline the submission management of cases to health authorities and distribution to partners. Central coding dictionary management automates semi-annual MedDRA, WHODrug, and EDQM updates. Vault Safety unifies pharmacovigilance systems and processes on a single cloud platform to deliver proactive patient safety. It leverages real-time reports and dashboards and seamless collaboration to provide visibility and compliance for adverse events.
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