SELTA SQUARE

AI/DX-powered PVaaS Platform

* PVaaS(Pharmacovigilance as a Service)

AI/DX-powered PVaaS platform delivering integrated capabilities across the entire Safety data flow—from monitoring and standardization to analytics and risk management.

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Key Features

Safety
DB

Data Entry & Reporting

Delivers AI-driven data entry for CIOMS and SAE reports, and provides robust MFDS-compliant submission capabilities for all foreign adverse event cases.

Literature
Monitoring

Automated Literature Monitoring

Executes automated literature searches and logging with a single query, while AI summarizes full texts and automatically detects ICSR candidates from narrative content.

Data Analysis
& Tabulation

For MFDS Product Renewal Report

Provides guideline-compliant tabulation for MFDS Product Renewal Reports and high-volume automated analytics for KAERS data.

Individual Case Processing Process

Safety Monitoring
Collect & Triage
Case Entry
MedDRA Coding
Quality Check
Medical Review
Effectiveness Validation
Regulatory Reporting
Integrated Analysis
Risk Management

Standardizing data into a Safety Data structure, and ICSR processing/reporting

Automatic case data entry 1Min
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Literature Monitoring Automation & AI-driven Safety Valid Case Detection

Case detection from literatures 2Min
More about Literature Monitoring >

Instant analysis results provided with a single click, even for large volumes of data

One-click tabulation 5Min
More about Data Analysis & Tabulation >

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