Tata Consultancy Services has announced a major upgrade to its TCS ADD™ Risk Based Quality Management Platform, introducing AI-powered capabilities that allow trial sponsors and CROs to move from reactive to predictive monitoring across clinical trial programs.
The latest release features fully interoperable modules, including:
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A redesigned Risk Assessment and Categorization Tool (RACT)
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An AI-driven Quality Tolerance Limit (QTL) module
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A robust Clinical Trial Analytics module for real-time performance insights
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A Subject Data Analytics module for centralised statistical monitoring and patient risk profiling
“These innovations represent our most comprehensive RBQM vision yet,” said Rachna Malik. “They empower clients with data-driven intelligence to speed up clinical development and improve oversight quality.”
The platform offers real-time risk monitoring, predictive insights, automated workflows, and integrated Quality by Design principles. It also supports regulatory expectations under ICH E6(R2) and E6(R3).
TCS revealed that a leading global pharmaceutical company achieved 30% efficiency improvement and 20% cost reduction by adopting the platform. The RBQM ecosystem now supports over 30,000 users across 1,300 de-risked studies at 32,000 sites worldwide.
