SELTA SQUARE

Celta Square (CEO Shin Min-kyung), an AI-based safety data company, announced on the 1st that it garnered attention by unveiling its post-marketing pharmacovigilance strategy and service vision based on real-world data (RWD) at the "2025 KoNECT-MOHW International Conference (KIC 2025)" held at the Lotte Hotel in Seoul from September 22nd to 24th.

At the 2025 KIC sponsored session, Lee Hye-jeong, Head of the Clinical Strategy Division, presented "Advancing Post-Marketing Surveillance in APAC and RWD-Driven Safety Evaluation." The presentation, which outlined the latest draft direction of the ICH M14 guideline, along with practical evaluation cases utilizing RWD and practical application strategies, garnered significant attention from both domestic and international stakeholders.

Through this presentation, Celta Square highlighted its active surveillance-based service system centered on RMP OneScope™ and AI-based data standardization technology, revealing its strategy for utilizing post-marketing drug safety surveillance data. This structure proactively responds to market changes, shifting from the passive surveillance centered on the existing Product Performance Survey (PMS) to a dynamic and flexible evaluation system centered on RMPs and Real-World Evidence (RWE).

Director Lee Hye-jeong stated, "Amidst the changing regulatory environment and the growing use of RWD, pharmacovigilance activities within RMPs are essential for effective safety management." She added, "Based on our expertise in pharmacovigilance, Celta Square can provide integrated pharmacovigilance through digital and AI technologies, not only RWD research that adheres to international standards, but also non-interventional studies such as PMSs and observational studies."

Meanwhile, Celta Square recently established a Clinical Strategy Headquarters and a Data Center, solidifying the potential for substantial expansion of its RWD-based pharmacovigilance strategy. Celta Square's Clinical Strategy Headquarters leads the way in domestic and international trends, including in APAC, and provides RMP-based pharmacovigilance research services as a partner with the execution capabilities to generate real-world safety evidence.