SeltaSquare

SeltaSquare Advances Global Pharmacovigilance Framework Based on Oracle Argus

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2026-05-08
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Oracle has partnered with SeltaSquare (CEO: Shin Min-kyung), an AI-based pharmacovigilance specialist company, to deliver comprehensive drug safety solutions targeting the Korean life sciences market. With Oracle Argus — Oracle's pharmacovigilance solution — at the center, SeltaSquare is providing safety case processing services to its clients, supporting patient safety and global regulatory compliance.


SeltaSquare is actively acquiring new customers through a Business Process Services (BPS) model and is emerging as a key partner for Oracle as it expands its business. SeltaSquare's Oracle Argus-based solution delivers a stable and comprehensive drug safety system to clients, contributing to regional growth and market expansion.


Leveraging Data Migration and Standardization Technology to Enhance Functionality and Efficiency

SeltaSquare has integrated its proprietary technology in the areas of data migration and safety data standardization to enhance the functionality and operational efficiency of the Oracle Argus platform. This has enabled the automation of the entire workflow — from case processing to global regulatory reporting — significantly minimizing manual work and reducing processing time.


In particular, SeltaSquare's solution has enabled seamless coordination with a wide range of international regulatory authorities, including Korea's Ministry of Food and Drug Safety (MFDS), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA), providing practical support for clients seeking to expand overseas and into global markets.


Oracle: "Supporting Global Pharmaceutical Companies with Next-Generation AI-Based Pharmacovigilance Technology"


CEO Shin Min-kyung of SeltaSquare stated: "The collaboration with Oracle is of great strategic importance to SeltaSquare. We will contribute to building a more effective and efficient pharmacovigilance framework in Korea alongside the advancement of the life sciences industry." She also emphasized that "Oracle Argus provides powerful pharmacovigilance capabilities that enable clients to respond flexibly to a rapidly changing regulatory environment while supporting business growth and global expansion."


Seema Verma, Executive Vice President and General Manager of Oracle Health and Life Sciences, also commented: "Oracle's pharmacovigilance solution is used by major pharmaceutical companies around the world to meet safety standards and accelerate drug safety processes. Oracle Argus is leading the way in next-generation multi-surveillance systems through AI-based automation technology and data science-driven innovation."


Supporting Safety Case Processing Across Drugs, Vaccines, and Devices


Oracle Argus is a proven pharmacovigilance solution equipped with the functionality to collect, process, analyze, and report adverse event cases for a wide range of products — including pre- and post-market drugs, biologics, vaccines, medical devices, and combination products. SeltaSquare leverages Argus's capabilities to help domestic and international pharmaceutical companies manage drug safety more swiftly and accurately.


Through this collaboration, SeltaSquare has refined its pharmacovigilance processes on the foundation of an AI-based automation system, while Oracle has further strengthened its foothold in the domestic life sciences market.



Oracle Official Announcement: https://www.oracle.com/news/announcement/selta-square-automates-pharmacovigilance-with-oracle-argus-2025-08-05/



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