At TCS, we don’t just help businesses transform. We help them become perpetually adaptive enterprises, built to evolve continuously and confidently in a world of constant change.
We deliver excellence and create value for customers and communities - everyday. With the best talent and the latest technology we help customers turn complexity into opportunities and create meaningful change.
Point of views, research, studies - on the latest themes - to help you expand your knowledge and be future ready.
At TCS, we believe exceptional work begins with hiring, celebrating and nurturing the best people — from all walks of life.
You have these already downloaded
We have sent you a copy of the report to your email again.
The newly upgraded platform empowers stakeholders with more proactive, analytics-led oversight across the trial lifecycle
MUMBAI, November 24, 2025: Tata Consultancy Services (TCS) (BSE: 532540, NSE: 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, said, “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.
Tata Consultancy Services (TCS) (BSE: 532540, NSE: TCS) is a digital transformation and technology partner of choice for industry-leading organizations worldwide. Since its inception in 1968, TCS has upheld the highest standards of innovation, engineering excellence and customer service.
Rooted in the heritage of the Tata Group, TCS is focused on creating long term value for its clients, its investors, its employees, and the community at large. With a highly skilled workforce of over 590,000 employees in 55 countries and 202 service delivery centers across the world, the company has been recognized as a top employer in six continents. With the ability to rapidly apply and scale new technologies, the company has built long term partnerships with its clients – helping them emerge as perpetually adaptive enterprises. Many of these relationships have endured into decades and navigated every technology cycle, from mainframes in the 1970s to Artificial Intelligence today.
TCS sponsors 14 of the world’s most prestigious marathons and endurance events, including the TCS New York City Marathon, TCS London Marathon and TCS Sydney Marathon with a focus on promoting health, sustainability, and community empowerment.
TCS generated consolidated revenues of over US $30 billion in the fiscal year ended March 31, 2025. For more information, visit www.tcs.com
corporate.communications@tcs.com
+91 22 6778 9098
y.tham@tcs.com
+65 6372 4822
tiffany.fisher@tcs.com
+1 416 456 7650
alma.leal@tcs.com
+521 55 2095 6098
francesca.newby@tcs.com
+61 414 902 440
roland.bagen@tcs.com
+46 70 3178024
douglas.foote@tcs.com
+81 80 2115 0989
pragya.priyadarshini@tcs.com
+971 528656700
priyanka.mehta@tcs.com
+44 7921493382
andrew.corcione@tcs.com
+1 646 617 8221
TCS Secures $1Bn Investment from TPG to Accelerate AI Data Center Business HyperVault
TCS recognized as the Most Valuable IT Services Brand in Asia
NHS Supply Chain Selects TCS to Transform Healthcare Delivery using AI & Cloud in a 5 Year Deal
TCS, Sybyl, and iXAfrica Partner to Accelerate Sovereign Cloud Adoption in East Africa