Qualio
Qualio is an all-in-one quality and compliance management platform built for small and growing businesses in life sciences and healthcare. Reliable, affordable, and easy to use, Qualio helps companies building life saving products get to market faster by reaching 100% ISO, GxP, and FDA compliance. With Qualio, companies can conveniently manage document control, training, CAPAs, NCRs, audits, suppliers, complaints, and more in one platform.
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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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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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Oracle Argus
The market-leading, trusted solution for processing, analyzing, and reporting adverse event cases originating in premarket and post-market drugs, biologics, vaccines, devices, and combination products. Transform your case management efficiency with innovative capabilities, such as built-in automation, workflow optimization, and conditional touchless processing. You can depend on Argus, a mature, reliable solution providing proven compliance with drug, vaccine, and device regulations and standards in all regions of the world, including E2B(R3), E2B(R2), eVAERS, eMDR, MIR, and IDMP. Argus Advanced Cloud includes Oracle Analytics, a powerful, flexible, AI-powered solution that empowers users to uncover new insights and make faster, more informed business decisions. Medicinal product safety teams face enormous pressure to control ever-increasing caseloads, new sources of signal detection data, and changing regulations, all with flat budgets and resources.
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