Express Pharma

TCS launches ADD AgentHub for agentic AI in drug development

The platform enables pharmaceutical companies to deploy AI agents across clinical development and pharmacovigilance while maintaining regulatory and audit requirements

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Tata Consultancy Services (TCS) has launched TCS ADD AgentHub, a role-based, enterprise-ready and trusted AI platform that enables the use of agentic AI in drug development at scale. The platform is designed to transform clinical trials and pharmacovigilance services while maintaining regulatory and audit requirements.

Pharmaceutical companies operate in regulated environments and face challenges related to trust, governance and scalability when applying AI across functions. Growing data volumes, fragmented systems and increasing regulatory expectations across clinical development and pharmacovigilance are adding complexities across the R&D value chain.

TCS ADD AgentHub provides a framework to address these challenges. Within the framework, AI agents can operate with clear roles, defined oversight and built-in auditability. Pharmaceutical companies can custom build their AI agent hub and deploy it across clinical workflows. The platform enables integration with minimal effort to accelerate adoption while maintaining regulatory compliance.

Built on the TCS ADD framework, TCS ADD AgentHub delivers operational benefits across drug development and drug safety functions. Solutions powered by the platform have demonstrated up to 40 per cent efficiency gains in clinical data management activities, up to 30 per cent reduction in clinical study build effort through metadata-driven automation and up to 30 per cent cost savings in end-to-end safety case processing. AI-powered safety agents can also reduce quality control effort by as much as 50 per cent.

Built on the TCS ADD agentic AI architecture, TCS ADD AgentHub enables pharmaceutical companies to deploy a Human + AI Operating Model in which AI agents are embedded into enterprise workflows, with humans retaining responsibility for governing and decision-making.

Debashis Ghosh, President, Lifesciences and Healthcare, TCS, said, “TCS ADD AgentHub, is a role-based, enterprise-ready, and trusted AI platform that will enable our customers to accelerate drug development using agentic AI at scale. It enables a shift from reactive to proactive, scalable, and audit-ready operations amidst an ever-changing regulatory environment. TCS’ strategy is to move towards autonomous enterprise functions where AI agentic workforce operates alongside humans driving innovation in drug development and improving patient safety.”

TCS ADD AgentHub supports workflows across clinical development and pharmacovigilance through AI workers for ICSR intake, data entry, coding, review and literature analysis; study design, protocol digitisation and clinical data review; SDTM (Study Data Tabulation Model) transformation; and medical monitoring assistance, among others.

The platform has an evolving catalogue of AI agents that can be deployed based on specific requirements and the existing landscape. These agents can be deployed progressively with minimal integration and implementation effort. By standardising how AI agents are deployed across these processes, the platform helps organisations improve productivity and enables scientific teams to focus on higher-value work.

TCS said its “AI-first” culture, exemplified by TCS ADD AgentHub, supports its aspiration to become the world’s largest AI-led technology services company. By leveraging the proprietary cognitive intelligence of the TCS ADD suite, TCS enables tangible, predictive and secure digital ecosystems for its customers.

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