Tata Consultancy Services (TCS) (BSE: 532540, NSE: TCS), a global leader in IT services and clinical trial oversight solutions, has introduced the next generation of its TCS ADD™ Risk Based Quality Management (RBQM) Platform. The enhanced platform now functions as an end-to-end, fully integrated system featuring AI-driven modules that help pharmaceutical and MedTech companies, personal care sponsors, CROs, and research institutes maintain proactive, intelligent, and compliant oversight throughout the entire clinical trial lifecycle.
Reimagining Quality Management in Clinical Research
Rachna Malik, Global Head of TCS ADD™, emphasized that today’s rapidly evolving research environment demands modernized approaches. She stated that traditional quality management models no longer suffice. As per the TCS press release, the new platform uses advanced analytics and AI to empower teams to make stronger data-driven decisions, optimize resources, and accelerate the delivery of life-changing therapies. Malik also highlighted that this release presents TCS’ most comprehensive vision for RBQM to date.
Enhanced Interoperability and User-Driven Configuration
Significantly, the upgraded modules now rank among the few fully interoperable RBQM solutions available worldwide. Moreover, the platform supports user-driven configuration, allowing teams to adapt it to various trial designs and monitoring models. This flexibility leads to higher adoption and faster deployment across diverse study setups. TCS also introduced four new modules focused on:
- Risk assessment and categorization
- Quality tolerance limits (QTL)
- Clinical trial analytics
- Subject data analytics
Advanced Modules for Smarter Oversight
- Integrated Risk Assessment and Categorization Tool (RACT)
The RACT module streamlines documentation and approvals using smart workflows that align with industry standards.
- Quality Tolerance Limit (QTL) Module
This AI-led statistical tolerance analytics tool leverages smart data inputs and an extendable QTL library to ensure study-specific insights.
- Clinical Trial Analytics Module
This module uses proprietary AI algorithms to detect issues in real time, monitor trial progress, and track site performance both centrally and on-site.
- Subject Data Analytics Module
It enables centralized monitoring of subject data using AI-driven patient profile risk scores, outlier detection, alerts, and workflow-supported data reviews.
AI-Driven Oversight Aligned with Global Regulations
The TCS ADD™ RBQM Platform combines artificial intelligence, machine learning, and advanced analytics to deliver real-time risk monitoring, predictive insights, automated workflows, and strong data quality oversight. Additionally, it aligns with recent regulatory guidelines, including ICH E6(R2) and E6(R3). The platform also embeds Quality by Design (QbD) principles from study planning through execution, ensuring continuous alignment between protocol risks, monitoring priorities, and data signals.
Proven Impact on Trial Quality and Efficiency
Early adopters have reported substantial gains. One of the world’s top three pharmaceutical companies improved monitoring efficiency by 30% and reduced site monitoring costs by 20% thanks to enhanced data quality. Furthermore, more than 30,000 users have used the platform to de-risk over 1,300 studies spanning 32,000 sites.
Advancing Toward Predictive Risk Management
With this latest release, TCS strengthens the TCS ADD™ suite of AI-powered, modern, open life sciences platforms. These tools help research teams transition from reactive to predictive risk management while simplifying data complexity and enabling faster access to effective therapies. Ultimately, the enhanced RBQM platform supports the creation of digital ecosystems that drive innovation and benefit patients worldwide.