Daewoong Pharmaceutical Selects Oracle Argus Safety Cloud and Techsol's Services for Optimizing its Global Drug Safety Operations

PRINCETON, N.J., March 28, 2019 /PRNewswire-PRWeb/ -- Established in 1945, Daewoong Pharmaceutical is a leading South Korean pharmaceutical company that has developed, manufactured, and commercialized innovative pharmaceuticals for both domestic and international markets, and aims to become a global player in the life sciences industry. Since it established its Vietnam branch in 2004, Daewoong has broadened its international operations by strategically establishing eight branches throughout Asia and the United States; opening research centers in China, India and Indonesia; and, expanding partnerships in more than 100 countries worldwide. With this expansion came the demand for global safety reporting compliance.

As a leader in Safety Case Management, Oracle Argus Cloud Service supports global standards such as E2B(R3), established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to meet ever-changing adverse event (AE) reporting requirements and prepare qualified documentation that varies by region. The Argus cloud-based adverse event reporting solution gives Daewoong the ability to generate electronic data in required formats for Individual Case Safety Reports and other documentation required for exporting prescription drugs and operating clinical trials.

"To support our global expansion, we needed a safety case management solution that would help ensure compliance with the regulatory reporting requirements of our existing global footprint, as well as the demands of our future regional expansion. Oracle Health Sciences Argus Cloud Service is an established and proven solution in the market, and was the obvious choice for us as we continue to grow globally. Daewoong Pharmaceutical will now be able to implement safety management according to international standards with Oracle Argus Cloud Service, as well as make better safety decisions throughout the clinical development lifecycle," said Hyunjin Park, Head of the development division in Daewoong Pharmaceutical.

"Regulations are constantly evolving and vary in every region. Oracle Health Sciences brings customers a codified solution that was built for a complex global operation like Daewoong's," said Bruce Palsulich, vice president of safety, Oracle Health Sciences. "We track regulatory developments worldwide to keep customers current and provide them tools to dynamically respond to these changes, so they can focus on developing and delivering effective medicines to those who need it most, and allow them to manage the safety of their therapies in the best way possible."

"We are delighted to join hands with Daewoong and Oracle Health Sciences as an extended technology partner for managing the Argus Safety application on Oracle's Cloud platform. With our drug safety domain knowledge, specialized consulting resources and regulatory compliant validation accelerators, we will continue to support the digital transformation of Daewoong's Pharmacovigilance operations with new version upgrades, preventive maintenance, training and other value-added consulting services." said Sriram Varma, Vice President of Service Operations, Techsol Corporation.

"As a preferred partner of Oracle especially in the Asia Pacific region, this engagement further strengthens our business relationship with Oracle Health Sciences group and paves way for a long-term commitment with Daewoong Pharmaceutical" said Satya S S Sagi, Founder & CEO, Techsol Corporation.

Additional Resources

• Oracle Health Sciences Argus Cloud Service
• Techsol Argus validation services

About Oracle Health Sciences

Oracle Health Sciences breaks down barriers and opens new pathways to unify people and processes to bring new drugs to market faster. As the number one vendor in Life Sciences (IDC, 2017), the number one provider of eClinical solutions (Everest Group, 2017) and powered by the number one data management technology in the world (Gartner, 2018), Oracle Health Sciences technology is trusted by 29 of the top 30 pharma, 10 of the top 10 biotech and 10 of the top 10 CROs for clinical trial and safety management around the globe.Oracle Health Sciences helps healthcare & life sciences organizations discover & develop innovative products & services to prevent & cure illness & enhance quality of life. Oracle offers a complete set of clinical and safety solutions that support critical processes throughout the clinical development lifecycle-from study design and startup to conduct, close-out, and post-marketing.

Reflecting Oracle's ongoing industry commitment, Oracle Health Sciences is uniquely positioned with the products, vision, resources, and industry expertise to fulfill existing and emerging needs in an environment characterized by the expansion of clinical trials and increased linkages across life sciences and healthcare.

About Techsol Corporation

Techsol Corporation (Techsol) specializes in offering cloud-based information technology services and innovative software solutions to global pharmaceutical, life sciences and healthcare companies. Founded in 2010, Techsol is a market leader in providing highly configurable process-oriented technology solutions for digitally transforming pharmaceutical business operations across medical affairs, clinical development and drug safety.

As an Oracle Gold Partner under Oracle Partner Network (OPN) program, Techsol is highly specialized in providing high-value technology services for the Argus Safety application. Having delivered over 100 projects to global pharmaceutical companies, Techsol is recognized as a trusted partner by Oracle for its expertise and domain knowledge in delivering services specifically around the Oracle Argus Safety Suite. For more information about Techsol Corporation, please visit us at http://www.techsolcorp.com

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Contact Info    
Jonathan Sun Kyu Kim
Techsol Corporation
+82-10-9766-0150
jonathan(dot)kim(at)techsolcorp(dot)com

SOURCE Daewoong Pharmaceutical Co., Ltd