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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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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TARA PV
TARA PV is a comprehensive, web-based pharmacovigilance safety database designed for processing, storing, analyzing, and reporting adverse events related to drugs, devices, and vaccines. Developed by MedGenesis Ltd, an ISO 9001 and ISO 27001 accredited UK-based software development company, TARA PV offers a user-friendly interface that is simple, intuitive, and fully compliant with 21 CFR Part 11, GxP, ICH standards, and global pharmacovigilance data protection regulations. As a cloud-based solution, TARA PV requires no installation and is accessible via an internet browser, enabling rapid implementation and integrated workflows for individual case assignments. The system provides full training upon deployment, with ongoing support available through an online ticketing system. Security is a priority, with hosting that features multiple redundancies and triple-layer backups. TARA PV offers a range of transparent pricing models with no hidden costs.
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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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