- Consulting services
IBM Star-AI for Healthcare and Life Sciences
Multi-agent GenAI automates adverse events, product quality, and medical insights—improving case throughput, data quality, and compliance across safety and quality workflows in HCLS.
Healthcare and life sciences organizations are under immense pressure to manage increasingly complex safety and quality requirements, all while ensuring compliance, accelerating time to market, and maintaining high standards for data integrity and patient safety. Traditional approaches to adverse event (AE) and product quality complaint (PQC) handling are often fragmented, manual, and difficult to scale—leading to delays, high operational costs, and growing regulatory risk.
IBM STAR Agentic AI is a next-generation, enterprise-grade platform designed to transform these high-value workflows through the power of generative AI, multi-agent orchestration, and real-time AI governance. Developed by IBM Consulting and built for deployment on Microsoft Azure, STAR introduces a fundamentally new way to manage AE and PQC workflows—by embedding intelligence at the point of process, orchestrating autonomous agents to handle tasks in parallel, and offering human-in-the-loop copilots to augment decision-making across roles.
Unlike legacy automation, STAR is not limited to static workflows or rule-based scripts. It brings together large language models, retrieval-augmented generation (RAG), semantic reasoning, and built-in compliance to dynamically adapt to context—whether classifying multilingual safety cases, generating structured narratives, coding events to MedDRA/WHODrug, or assembling regulatory-ready documentation for global submission. The result is a more resilient, explainable, and efficient system that delivers real ROI at scale.
Deployed as an Azure-native solution, STAR integrates with Microsoft's ecosystem—including Azure OpenAI, Cognitive Search, Power BI, Logic Apps, Dataverse, SharePoint, and enterprise safety platforms like Argus, ArisGlobal, and TrackWise. The architecture is built for extensibility and security, with full support for HIPAA, GDPR, GxP, and FDA 21 CFR Part 11 standards. Real-time audit trails and AI explainability features ensure that every action is traceable and defensible.
STAR is already has accelerated case processing times by over 60%, reduced manual handoffs and reviewer burden, and increased consistency in regulatory filings. Use cases include AI-powered case intake, automated triage, co-pilot–assisted medical review, narrative generation, PQC lifecycle management, and root cause investigations. These intelligent workflows free up scientists to focus on complex assessments, reduce time-to-submit from months to weeks, and enable continuous inspection readiness across geographies.
Getting started with STAR is straightforward. IBM Consulting offers a proven implementation approach tailored to the client’s Azure environment, with co-investment models available to support proof-of-concept, deployment, and change management. As part of the engagement, clients receive an IBM ICA4AA framework that leverages IBM IP for accelerating platform and use case deployment and configuration.
STAR represents more than a technology shift—it is a digital transformation framework for regulated operations in life sciences. As Microsoft clients increasingly turn to AI to modernize core functions, STAR provides a safe, scalable, and strategic path to achieve intelligent compliance, operational efficiency, and sustained business value.