TCS Launches Next-Generation AI-Powered RBQM Platform for Smarter, Faster Clinical Trials
The enhanced platform introduces four new interoperable modules: risk assessment and categorisation, quality tolerance limits, clinical trial analytics, and subject data analytics.
Tata Consultancy Services (TCS) has unveiled the next generation of its TCS ADD™ Risk-Based Quality Management (RBQM) Platform. The upgraded end-to-end platform introduces a comprehensive suite of AI-driven modules designed to provide pharmaceutical companies, MedTech firms, personal care sponsors, CROs, and research institutes with proactive, intelligent, and regulatory-compliant oversight across the clinical trial lifecycle.
“The platform’s AI and advanced analytics capabilities enable our clients to make data-driven decisions, optimise resource allocation, and ultimately bring life-changing therapies to patients faster and more efficiently. This version represents our most comprehensive vision yet for RBQM,” Rachna Malik, Global Head, TCS ADD™, said.
The enhanced platform introduces four new interoperable modules: risk assessment and categorisation, quality tolerance limits, clinical trial analytics, and subject data analytics. These modules allow user-driven configuration to support diverse trial designs and monitoring models, ensuring faster deployment.
The RACT module offers smart workflows for streamlined documentation and approvals, while the QTL module provides AI-led statistical tolerance analytics through an extendable library.
The Clinical Trial Analytics module uses proprietary AI algorithms to monitor site performance and identify issues in real-time. Meanwhile, the Subject Data Analytics module centralises statistical monitoring with AI-based risk scoring, outlier detection, and automated alerts.
Aligned with ICH E6(R2)/E6(R3) guidelines and Quality by Design (QbD) principles, the platform enables predictive insights, automated workflows, and continuous risk monitoring.
Early adopters have reported up to 30% improvement in trial monitoring efficiency and 20% reductions in site monitoring costs. With more than 30,000 users and 1,300 studies supported, the latest release reinforces TCS ADD™ as a leader in AI-powered clinical research transformation.
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