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Oracle Customer Success — Dong-A ST
Dong-A ST Improves Risk Management and Ensures International Regulatory Compliance Through More Timely and Complete Drug-Safety Information
ShareThanks to Oracle Argus Safety, we gained a comprehensive, web-based pharmacovigilance platform to improve the efficiency and reliability of critical drug-safety information. We created faster regulatory reports and shared timely and complete drug-safety information with our international partners, enabling us to improve risk management and meet global compliance standards.
— Su Won Kim, Drug Safety Manager, Dong-A ST
Established in 2013, Dong-A ST is a leading global pharmaceutical company focused on developing prescription drugs, medical devices, and diagnostics. As a subsidiary of Dong-A Pharmaceutical Co., Ltd., the company has built a world-class research institute and is actively exploring overseas markets while expanding its global product portfolio to encompass biomedicine, generic, and recently introduced pharmaceuticals.
Challenges
- Establish an efficient, secure, and flexible pharmacovigilance platform to improve drug-safety information management and meet stringent domestic and international pharmaceutical-safety regulation standards
- Automate the collection of drug safety information from pharmacovigilance activities to support critical decisions for introducing new drug licenses and biotechnology contracts and to improve risk management
- Ensure timely responses to serious adverse drug reactions, including incidents that occur overseas, within 15 days to meet new regulatory reporting requirements
Results
- Reduced human resources costs and boosted business productivity by implementing a comprehensive, web-based, pharmacovigilance platform to extract, transfer, and load safety data, including information from clinical trials, as well as drug dosages and formulas, instead of relying on hard-copy documents
- Ensured compliance with domestic and international pharmaceutical-safety standards by creating faster regulatory reports to analyze complex pharmaceutical-safety data, thanks to Oracle Argus Safety’s multidimensional analysis feature
- Supported more confident and rapid decision-making for introducing new drugs or removing existing drug licenses by automating the collection of drug-safety information from pharmacovigilance activities, enhancing competitiveness
- Enabled faster responses to serious adverse drug-reaction incidents to meet new regulations by using a dashboard to share timely and complete safety data between global pharmaceutical partners and regulatory bodies, and to enable drill-down analysis of overseas incidents, improving risk management
- Provided a flexible and secure pharmacovigilance platform to support global expansion
Why Oracle
Dong-A ST considered several competitors’ products offered domestically and internationally. It chose Oracle Argus Safety for its recognized reputation in the global pharmaceutical marketplace, robust reporting features, and its flexible licensing.
Oracle Argus Safety’s flexible licensing model met our long-term business requirements and enabled us to expand further into international markets, enhancing our global competitiveness.
— Su Won Kim, Drug Safety Manager, Dong-A ST
Execution
With support provided by Oracle partners, TAKE solutions and Time Gate Co., Ltd., Dong-A ST was the first company in Korea to implement Oracle Argus Safety. It completed the implementation in six months. The company also smoothly migrated its historical data to the new platform.
About Dong-A ST
Headquarters
Seoul, Korea
Employees
1,605
Annual Revenue
$100 to $500 Million
Partners
Dong-A ST’s internal IT team worked with Oracle partner TAKE Solutions for data migration and user training, and it used Oracle partner Time Gate Co., Ltd. for technical support.
“With TAKE Solutions’ wealth of experience and know-how in working with drug-safety requirements and Time Gate’s deep understanding of our business requirements, we gained a world-class pharmacovigilance platform that could support our global expansion and meet international regulatory requirements,” Kim said.
Oracle Solutions Used
Published: Jan 05, 2015