Revolutionizing Clinical Trials: TCS Debuts AI Oversight Platform

Published: 25 Nov 2025

Author: Precedence Research

Share :

Tata Consultancy Services (TCS) has unveiled a cutting-edge AI-driven platform to simplify clinical trial supervision. The platform, a component of TCS's ADD Risk-Based Quality Management (RBQM) suite, provides research institutions and pharmaceutical companies with real-time insights into potential risks, enabling them to identify and resolve issues much earlier than with conventional monitoring techniques. This new approach improves accuracy in detecting trial deviations. It also supports faster decision-making through continuous data flow.

The platform includes four AI-powered modules: risk assessment, quality tolerance limits, trial analytics, and patient-level data monitoring. Because of these modules' great degree of configurability, research teams can modify them to fit various kinds of clinical studies. By doing this, the platform reduces setup time and boosts productivity throughout the clinical trial process. This flexibility significantly reduces setup time. The platform also integrates smoothly with existing clinical data systems.

In today's quickly changing research environment, traditional monitoring techniques frequently fall short, according to Rachna Malik, Global Head of TCS ADD. Sponsors can make better decisions, allocate resources more wisely, and expedite the development of novel treatments while maintaining patient safety by utilizing AI-driven insights. The approach improves coordination across global study teams. It also leads to more consistent outcomes across all trial sites.

The launch aligns with the growing adoption of AI in clinical research, particularly within India’s healthcare sector. The platform complies with global regulatory guidelines, such as ICH E6(R2) and the upcoming E6(R3), and incorporates Quality by Design (QbD) principles to ensure high-quality trials from the start. This makes the platform a critical tool for organizations aiming to enhance trial efficiency and compliance. This ensures stronger compliance and better patient safety from day one. It also makes regulatory reporting smoother and more data-driven.

As evidence of its scalability and efficacy, TCS's AI platform has already been used in more than 1300 clinical trials at 32000 locations worldwide. TCS is setting a new standard for clinical research by using AI for trial oversight, enabling the delivery of life-saving treatments more quickly, safely, and effectively. The platform is positioned as a future-ready tool for global life science companies. It marks a major step toward faster, safer, and more cost-efficient trial execution.