Tepsivo
Tepsivo's pharmacovigilance software solutions are designed to streamline drug safety processes through automation and smart templates, significantly reducing administrative burdens and associated costs. The Tepsivo Platform is a comprehensive, cloud-based application that allows users to manage all pharmacovigilance activities in one centralized location. Key features include a Quality Management System, Local Contact Person for Pharmacovigilance (LCPPV) oversight, streamlined safety reporting and follow-up tools, PSUR tracking, signal management tracking, automated audit trails, compliance tracking, adverse event intake tools, literature monitoring, risk management system tracking, PSMF management solutions, automated partner reconciliation, and CAPA management. These integrated modules ensure full transparency, 100% compliance, inspection readiness, high quality, rapid speed, no administrative overhead, and minimal cost.
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Cloudbyz Safety and Pharmacovigilance (PV)
Cloudbyz Safety & Pharmacovigilance Solution is a cloud-based software solution designed to streamline the drug safety and pharmacovigilance operations for pharmaceutical and life science companies. The solution helps to automate the process of collecting, processing, analyzing and reporting adverse event data in compliance with global regulatory requirements. Cloudbyz Safety & Pharmacovigilance Solution enables companies to reduce risk, improve compliance, and enhance patient safety while accelerating drug development.
Cloudbyz provides end-to-end management of the pharmacovigilance lifecycle, including adverse event processing, case management, regulatory reporting, signal detection, and risk management. With Cloudbyz, you can optimize your pharmacovigilance processes, accelerate case processing, and increase the accuracy of your safety data, while minimizing risk and ensuring compliance.
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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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Dialog
Dialog offers a modular, end-to-end pharmacovigilance literature monitoring solution that supports organizations tasked with drug safety reporting by streamlining and automating the entire literature triage process. It provides access to over 140 authoritative scientific and medical literature databases, such as MEDLINE, Embase, and Biosis, standardizing content across sources to ensure consistent precision search, deduplication, and structured XML output. The DialogML engine employs artificial intelligence to rank search results by patient-safety relevance, highlight key safety concepts, and tag references related to ICSRs (Individual Case Safety Reporting), aggregate reports (PBRER, PSUR, DSUR), and safety signals, so reviewers can rapidly identify high-priority articles. The Dialog Alerts Manager simplifies alert creation and management, offering bulk editing, audit trails of search strategy changes, scheduling flexibility, and delivery history tracking.
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