As clinical trials grow more complex, Tata Consultancy Services (TCS) has launched a significantly enhanced version of its TCS ADD™ Risk Based Quality Management Platform, positioning it as one of the most comprehensive AI-driven solutions in global clinical research today.
The new platform integrates four expanded modules:
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RACT with automated, standards-aligned workflows
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QTL, a study-specific AI-led tolerance analytics engine
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Clinical Trial Analytics offering proprietary AI insights
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Subject Data Analytics enabling centralised statistical monitoring and smart alerts
These tools allow sponsors and CROs to identify risks earlier, track site performance, detect patient-level outliers, and automate review workflows.
“Traditional quality systems just cannot keep pace anymore,” said Rachna Malik, Global Head of TCS ADD™. “Our platform’s AI capabilities directly improve decision-making and enable faster delivery of life-changing therapies.”
Built to comply with ICH E6(R2) and future E6(R3) expectations, the platform embeds Quality by Design, linking protocol risks with real-time data signals and monitoring priorities.
Early adoption success includes a 30% increase in monitoring efficiency, 20% reduction in site monitoring costs, and more than 1,300 de-risked studies involving 32,000 sites. Over 30,000 users now leverage the platform across global programs.
