Case Study: Dong-A ST achieves faster regulatory reporting and improved risk management with Oracle Argus Safety (Oracle)

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Preview of the Dong-A ST Case Study

Dong-A ST Improves Risk Management and Ensures International Regulatory Compliance Through More Timely and Complete Drug-Safety Information

Dong‑A ST is a Seoul‑based global pharmaceutical company (est. 2013) developing prescription drugs, medical devices, diagnostics and biologics as it expands into overseas markets. The company needed an efficient, secure, and flexible pharmacovigilance platform to automate collection and management of drug‑safety information, meet stringent domestic and international regulatory standards, and ensure timely reporting of serious adverse drug reactions (including overseas incidents) within a 15‑day window.

Working with Oracle partners TAKE Solutions and Time Gate, Dong‑A ST implemented the web‑based Oracle Argus Safety platform and migrated historical data in six months. The solution eliminated paper workflows, reduced HR costs, and boosted productivity; enabled faster, multidimensional regulatory reporting to ensure compliance; automated safety‑data collection to support licensing and risk decisions; and delivered dashboards and drill‑down analytics for quicker responses to international incidents, supporting the company’s global expansion.


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Dong-A ST

Su Won Kim

Drug Safety Manager


Oracle

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