Business

TCS Enhances Clinical Trial Oversight with AI-driven TCS ADD™ RBQM Platform Upgrade

By Desk Business

Tata Consultancy Services has launched its most advanced version yet of the TCS ADD™ Risk Based Quality Management Platform, offering pharmaceutical and MedTech stakeholders a new level of intelligent, proactive, and compliant oversight across clinical trials.

The platform integrates AI, machine learning, advanced analytics, and automated workflows to address growing complexity in clinical research. The latest updates include four new interoperable modules for risk assessment, quality limits, trial analytics, and subject-level analytics.

According to Rachna Malik, Global Head of TCS ADD™, the enhanced platform “reimagines how clinical trials are monitored and managed,” enabling faster, data-driven decisions and improved resource allocation.

The new modules include:

  • RACT Module: Smart workflows for standardized documentation and approvals.

  • QTL Module: AI-led statistical tolerance analytics with a comprehensive QTL library.

  • Clinical Trial Analytics: Proprietary algorithms for real-time snag identification and performance tracking.

  • Subject Data Analytics: AI-driven risk scores, outlier detection, and smart alerts.

The platform aligns with regulatory standards such as ICH E6(R2) & E6(R3) and embeds Quality by Design principles, ensuring continuous connection between study design, protocol risks, monitoring priorities and real-time data signals.

Early adopters have already seen a 30% jump in trial monitoring efficiency and a 20% drop in site monitoring costs. With 30,000+ users, 1,300+ de-risked studies, and 32,000 participating sites, the platform continues to drive global transitions from reactive to predictive risk management.

Desk Business