Tata Consultancy Services has introduced TCS ADD™ AgentHub, a role-based, enterprise-ready, and trusted AI platform designed to support the use of agentic AI in drug development at scale. The platform is intended to help pharmaceutical companies apply AI across critical operations while addressing regulatory and audit requirements. TCS ADD™ AgentHub is positioned to transform clinical trials and pharmacovigilance services by providing a structured environment in which AI agents can work within clearly defined roles and oversight frameworks.
Pharmaceutical companies operate within highly regulated environments and continue to encounter challenges involving trust, governance and scalability as they expand AI adoption across different functions. At the same time, growing data volumes, fragmented systems, and increasing regulatory expectations across clinical development and pharmacovigilance are creating additional complexity throughout the R&D value chain.
TCS ADD™ AgentHub is designed to address these issues by giving organizations a framework where AI agents can function with clear responsibilities, defined oversight, and built-in auditability. Pharma companies can custom build their AI agent hub and deploy them across clinical workflows, while the platform supports rapid and streamlined integration with minimal effort. This approach is intended to accelerate adoption while maintaining regulatory compliance and strengthening the application of AI in drug development.
Operational Gains Across Clinical and Safety Functions
Built on the TCS ADD™ framework, TCS ADD™ AgentHub is designed to deliver measurable operational benefits across drug development and drug safety functions. Solutions powered by the platform have demonstrated up to 40% efficiency gains in clinical data management activities, while metadata-driven automation has enabled up to 30% reduction in clinical study build effort. The platform has also demonstrated up to 30% cost savings in end-to-end safety case processing. In addition, AI-powered safety agents can reduce quality control effort by as much as 50%, supporting productivity improvements across critical R&D processes.
Built on the TCS ADD™ agentic AI architecture, the platform enables pharma companies to deploy a Human + AI Operating Model, embedding AI agents into enterprise workflows while humans continue to retain 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.”
AI Workers Across Clinical Development and Pharmacovigilance
TCS ADD AgentHub supports workflows across clinical development and pharmacovigilance through AI workers covering ICSR intake, data entry, coding, review, and literature analysis, study design, protocol digitization, 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 selected according to specific needs, requirements, and landscape.
These agents can be deployed progressively and rapidly with minimal integration and implementation effort. By standardizing the deployment of AI agents across these processes, TCS ADD™ AgentHub is designed to help organizations improve productivity while enabling scientific teams to concentrate on higher-value work. Buoyed by its comprehensive “AI-first” culture, perfectly exemplified by TCS ADD™ AgentHub, TCS aspires 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.
