SeltaSquare

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SeltaSquare, an AI-powered pharmacovigilance (PV) company led by CEO Minkyung Shin, announced that it has been named as a Sample Vendor in the AI-Augmented Safety Vigilance category of the Gartner® Hype Cycle™ for Life Science R&D, 2026 report. The category includes 10 companies.

This Hype Cycle helps CIOs prioritize digital investments, resulting in accelerated speed to market, reduced costs and enhanced productivity. Gartner explains, “Life science R&D is unifying real and in silico workflows to innovate discovery, clinical and product development processes.”

Against this backdrop, Gartner identifies AI-Augmented Safety Vigilance as a key technology area. According to the report, AI-augmented safety vigilance “entails the use of new technologies, such as GenAI, agentic AI and business optimization and automation technologies (BOAT), to augment and optimize solutions specialized in adverse event (AE) detection and processing.” Furthermore, Gartner notes that “Integrated safety platforms, combined with AI models, have the potential to transform safety vigilance solutions and significantly reduce operational costs, while retaining high quality and ensuring compliance,” These include the ability to identify AEs in large amounts of healthcare data, detect subtle patterns and signals of new drug interactions, and streamline and automate data intake, triage, routing, processing and reporting.

The report also states that "The demand to enhance and optimize safety processes drives the need to build integrated, cloud-based safety vigilance platforms, and use these augmented capabilities to manage the complete end-to-end process," and that "With the influx of AE reporting due to RWD, AI tools are now required, available and able to further enhance and automate signal detection, AE medical coding, case triage, routing and form autocompletion."

According to SeltaSquare, these technology trends align with the company's ongoing efforts to advance the digital transformation of pharmacovigilance. The company states that it has continued to enhance its AI-based PV platform by combining artificial intelligence capabilities with pharmacovigilance expertise to support use in regulated environments.

SeltaSquare's AI-powered pharmacovigilance platform, iVigilance Square, is designed to support key pharmacovigilance functions, including safety database management, literature monitoring, E2B(R3) XML conversion, data analytics, and MedDRA coding within a single platform.

According to the company, the platform incorporates an Explainable AI (XAI) framework and a Human-in-the-Loop operating model in which AI supports large-scale data processing while qualified professionals retain responsibility for medical assessment and decision-making. SeltaSquare states that this approach is intended to enhance transparency, reliability, and regulatory readiness in AI-supported pharmacovigilance workflows.

Minkyung Shin, CEO of SeltaSquare, commented: "AI-enabled pharmacovigilance is an important technology area that may contribute to the future evolution of safety management practices across the pharmaceutical and biotechnology industries. We believe our inclusion as a Sample Vendor in the Gartner® Hype Cycle™ for Life Science R&D, 2026 reflects the alignment of our AI-based pharmacovigilance strategy with broader industry technology trends. We will continue to advance our integrated pharmacovigilance platform with a focus on regulatory requirements and GxP compliance while supporting faster and more informed decision-making by safety professionals."

Source Attribution

Source: Gartner®, Hype Cycle™ for Life Science R&D, 2026, Reuben Harwood, Jeff Smith, 12 June 2026

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