PvEdge
PvEdge is a cloud-ready pharmacovigilance software designed to provide end-to-end compliant safety solutions for drugs, devices, vaccines, and combination products. It offers a comprehensive safety database that manages pharmacovigilance intake, case processing, submissions, AI & analytics, and safety signals all in one platform. The system adheres to existing and upcoming regulations, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, ensuring global compliance. PvEdge utilizes advanced automation powered by AI and machine learning algorithms to enhance efficiency in drug safety database management. Key features include automated literature monitoring, ICSR submissions, smart triage, automated signal detection, and document automation. The platform also provides a controlled document management system for creating, managing, and publishing pharmacovigilance documents, as well as a risk-based enterprise quality management system to implement quality processes and training records.
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DF mSafety AI
DF mSafety AI is a cloud-based safety platform that leverages AI/ML and automation to enhance efficiency and user experience in safety case management and signal detection for drugs, cosmetics, vaccines, nutraceuticals, and medical devices. Built on Datafoundry's loud platform, DF Safety 4.0, it supports scalable and secure AI/ML-driven safety case and signal management, with pre-built connectors to enterprise systems, adhering to regulatory requirements and industry standards. Key features include multi-source case intake options, automated triage rule configuration, seriousness prediction, causality assessment, expectedness and listedness assessment, auto narrative generation, custom report generation, literature monitoring for safety, signal and risk management, case compliance alerts, integrated MedDRA and WHO-DD browsers, enhanced E2B R2 & R3 compliance, and an e-submissions gateway.
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Oracle Life Sciences Empirica
Oracle Life Sciences Empirica is the market-leading solution for detecting, analyzing, and managing safety signals originating in pre- and post-market drugs, biologics, vaccines, devices, and combination products. Oracle continually researches, develops, and advances the state-of-the-art data-mining algorithms and statistical techniques used in Empirica. By enabling the detection of signals with a longer lead time, Empirica can provide risk insights 7 to 22 months earlier than labeling revision dates from a time-indexed benchmark. Safety teams responsible for signal management face new challenges, such as finding hidden signals, assessing information from multiple big data sets, and providing better safety information before clinical trials even begin. Read our ebook to learn how new advances in methodologies and technologies, such as artificial intelligence, can help address these challenges.
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Smart Inventory Planning & Optimization
Smart Software is a leading provider of demand planning, inventory optimization and supply chain analytics solutions headquartered in Belmont, Massachusetts, USA. Founded in 1981 Smart has helped thousands of customers plan for future demand utilizing industry-leading statistical analytics. Smart Inventory Planning & Optimization (IP&O) is the company’s next-generation suite of native web applications, helping inventory carrying organizations reduce inventory, improve service levels and streamline Sales, Inventory, and Operations Planning.
Smart IP&O, hosted on Amazon Web Services, is a Digital Supply Chain Platform driving three applications: demand planning, inventory optimization, and dashboard reporting. Smart IP&O functions as a transparent extension of our customers’ ERP systems of choice, receiving daily transaction data and returning forecasts and inventory policy values to drive replenishment and production planning.
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