Tata Consultancy Services (TCS) (BSE: 532540, NSE: TCS), a global leader in IT services and a major provider of clinical trial intelligence and quality oversight solutions, has unveiled the next generation of its TCS ADD™ Risk Based Quality Management (RBQM) Platform. The upgraded, end-to-end integrated platform introduces a suite of AI-powered modules designed to help pharmaceutical and MedTech companies, personal care sponsors, CROs, and research institutes achieve proactive, analytics-led oversight across the clinical trial lifecycle.
“Traditional approaches to quality management are no longer sufficient,” said Rachna Malik, Global Head, TCS ADD™. “Our advanced RBQM platform reimagines how clinical trials are monitored and managed. With AI and advanced analytics, clients can make data-driven decisions, optimize resources, and bring therapies to patients faster.”
The platform now features four new fully interoperable modules:
-
Risk Assessment and Categorization Tool (RACT) with smart workflows aligned to global documentation and approval standards.
-
Quality Tolerance Limit (QTL) module, an AI-driven statistical tolerance analytics tool supported by a robust and extendable QTL library.
-
Clinical Trial Analytics module offering proprietary AI algorithms for real-time issue detection, central and on-site monitoring, and site performance tracking.
-
Subject Data Analytics module for centralized statistical monitoring with AI-driven patient profile risk scoring, outlier detection, and automated alerts.
Built on AI, machine learning and advanced analytics, the upgraded RBQM platform delivers real-time risk monitoring, predictive insights, automated workflows and enhanced data quality oversight. It aligns with evolving regulatory guidelines including ICH E6(R2) and the upcoming E6(R3), while integrating Quality by Design (QbD) principles from study design through execution.
Early adopters have reported significant operational gains. A top-three global pharmaceutical company achieved a 30% rise in monitoring efficiency and reduced site monitoring costs by 20% due to improved data quality. To date, more than 30,000 users have engaged with the RBQM platform, supporting over 1,300 de-risked studies across 32,000 sites.
With this release, TCS ADD™ strengthens its position as a leader in AI-powered life sciences platforms that simplify data complexity, build digital ecosystems, and accelerate access to effective new drugs for patients worldwide.
