TCS Enhances Clinical Trial Efficiency With Advanced RBQM Platform

Tata Consultancy Services (TCS), a global leader in IT services, consulting, and business solutions, and a leading provider of clinical trial intelligence and quality oversight solutions, has launched the next generation of the TCS ADD™ Risk Based Quality Management (RBQM) Platform. The latest version is an end-to-end integrated platform which has a suite of AI-powered modules designed to equip pharmaceutical and MedTech companies, personal care sponsors, CROs (Clinical Research Organization), and research institutes with proactive, intelligent, and compliant oversight across any clinical trial lifecycle.

Rachna Malik, Global Head, TCS ADD™, Tata Consultancy Services “In today's rapidly evolving clinical research environment, traditional approaches to quality management are no longer sufficient. Our Advanced TCS ADD™ Risk Based Quality Management Platform reimagines how clinical trials are monitored and managed. The platform’s AI and advanced analytics capabilities enable our clients to make data-driven decisions, optimize resource allocation, and ultimately bring life-changing therapies to patients faster and more efficiently. This version represents our most comprehensive vision yet for RBQM.”

The upgraded modules are now among the few fully interoperable modules available globally. This module also allows user-driven configuration to support various trial designs and monitoring models, enabling higher adoption and faster deployment. The current version has four new modules for risk assessment and categorization, quality tolerance limit, clinical trial analytics, and subject data analytics.

The integrated Risk Assessment and Categorization Tool (RACT) module with smart workflows ensures documentation and approvals in alignment with industry standards. The Quality Tolerance Limit (QTL)module is a study-specific AI-led statistical tolerance analytics tool powered by smart data input and a comprehensive and extendable QTL library. The Clinical Trial Analytics module offers advanced analytics with proprietary AI algorithms to identify snags in real-time, monitor trials, and track site performance centrally and on-site. On the other hand, the Subject Data Analytics module enables centralised statistical monitoring of subject data through AI-driven patient profile risk scores, outlier detection, and alerts/notifications with smart workflows for data reviews.

The TCS ADD™ Risk Based Quality Management Platform leverages artificial intelligence, machine learning, and advanced analytics to provide real-time risk monitoring, risk assessment and categorisation, predictive insights, and automated workflows along with data quality oversight. This innovative approach addresses the growing complexity in monitoring and managing clinical trials in the modern research landscape and aligns with the latest regulatory guidelines, including ICH E6(R2) and E6(R3). The platform also integrates Quality by Design (QbD) principles from study design through execution, enabling real-time connection between protocol risks, monitoring priorities, and data signals.

Early adopters of the TCS ADD™ Risk Based Quality Management platform have reported significant improvements in trial efficiency and quality. One of the top 3 pharmaceutical companies globally has achieved a 30% efficiency increase in trial monitoring and oversight while simultaneously reducing site monitoring costs by 20% due to improvement in data quality. With over 30,000 users engaged with TCS ADD™ Risk Based Quality Management platform, over 1,300 studies have been de-risked over 32,000 sites. With the latest release, TCS ADD™ continues to lead in delivering practical, intelligent solutions that help research teams transition from reactive to predictive risk management. The newly added module strengthens the TCS ADD™ suite of AI powered modern and open life sciences platforms that enable digital ecosystems, simplify data complexity and provide faster access to new and effective drugs for patients in need.