SeltaSquare

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Contributing to Improved Operational Efficiency and Quality with an AI-Based Safety Data Solution

SeltaSquare, a pharmacovigilance specialist company, has announced a significant enhancement to SELTA-WAVE, its AI-based solution that revolutionizes safety data entry and reporting workflows.

SELTA-WAVE is a Safety Data Solution developed using SeltaSquare's proprietary AI technology. It automatically converts safety data from a wide range of sources — including CIOMS reports, SAE Reports, and the KAERS database — into E2B(R3) XML format, dramatically reducing the time required for data entry. The converted outputs can be immediately used for downstream tasks such as Safety Database uploads, regulatory authority reporting, and partner company transmission, thereby improving the overall efficiency of the pharmacovigilance process.

The newly enhanced reporting functionality is particularly effective for pharmaceutical companies that report safety cases collected overseas — in R3 XML format — to Korea's Ministry of Food and Drug Safety (MFDS). The feature was developed in response to requests from pharmacovigilance professionals who frequently communicate with global headquarters or sponsor companies, and delivers meaningful practical convenience in day-to-day operations.

With SELTA-WAVE, users can now complete all required tasks within the platform — including entering mandatory Korean (KR) fields for MFDS reporting, submitting reports, and making amendments — without needing to log in separately to Nedrug. This enables pharmacovigilance professionals handling safety cases from global clinical trials or overseas partner companies to process their reporting tasks more swiftly and accurately.

The SELTA-WAVE Development Lead commented: "The automated MFDS reporting feature for overseas safety cases was developed directly in response to feedback from frontline pharmacovigilance professionals. We expect it to significantly improve the operational efficiency of domestic pharmaceutical companies that collaborate with global pharma partners."

CEO Shin Min-kyung of SeltaSquare stated: "Pharmacovigilance staff at pharmaceutical companies spend a considerable amount of time manually entering and converting safety information. SELTA-WAVE automates these repetitive tasks, helping to boost operational efficiency and improve data accuracy."

Currently, major domestic and international pharmaceutical companies — including Johnson & Johnson, Daewoong Pharmaceutical, Yuhan Corporation, and Santen Korea — are utilizing SELTA-WAVE, with growing inquiries coming particularly from companies conducting global clinical trials or those with overseas partner organizations.

In celebration of the enhanced features, SeltaSquare is offering a free trial to pharmaceutical companies that inquire through its official website. Companies interested in pharmacovigilance workflow automation can apply for a trial or consultation via the website.

Read the Original Articles:

• Money Today: SeltaSquare Enhances Capabilities of Pharmacovigilance Automation Solution 'SELTA-WAVE'
• NBN TV: SeltaSquare Improves MFDS Reporting Accuracy with SELTA-WAVE

Learn More About SELTA-WAVE: https://www.seltaglobal.com/ko/solution/wave