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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CoVigilAI
CoVigilAI is an AI-enabled medical literature monitoring solution that employs advanced algorithms and data analytics to proactively detect and manage adverse drug events, ensuring patient safety and regulatory compliance in real time. The platform offers streamlined tracking of scientific and medical publications across prominent global literature databases such as PubMed and Embase, with customizable search strings facilitating an effortless pharmacovigilance literature monitoring journey. Periodic surveillance of scientific and medical literature databases and publications from diverse local journals is conducted, encompassing both global literature monitoring and localized literature surveillance. Advanced algorithms categorize Individual Case Safety Reports (ICSRs) into valid, potential, and invalid cases, while automated key entity detection efficiently recognizes crucial entities like patients, medications, adverse events, and designated medical events.
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Drug Safety Triager
Drug Safety Triager is Clarivate's next-generation pharmacovigilance software designed to assist life sciences organizations in meeting regulatory requirements. This GxP-validated, compliant, and audit-ready system manages and streamlines the literature review workflow, enabling pharmacovigilance experts to focus on patient safety by simplifying literature review processes. The platform is fully validated and compliant with the reporting requirements of global safety regulatory agencies such as the FDA and EMA. Each implementation of the Drug Safety Triager is delivered with a validation package. The validation process and associated documentation align with the pharmaceutical industry and health authority regulations. All literature references undergo a systematic review process that automatically captures all users’ actions and adds a permanent, non-editable audit trail to the record.
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IQVIA
Thousands of organizations around the world trust IQVIA to speed drug development, ensure product quality and safety, improve commercial effectiveness, get the right treatments to patients, improve access to and delivery of healthcare, and ultimately drive better health outcomes. Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster. With a foundation in data, advanced analytics, and expert insight, IQVIA brings specialized capabilities to customers across the healthcare ecosystem. Read and watch the latest from IQVIA data scientists, doctors, researchers, and other subject matter experts on the topics that matter to you. From industry trends to how we are applying our capabilities to help, you can find it here.
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