This initiative will help pharma industry scale AI with confidence across the R&D value chain in highly regulated environments.
Tata Consultancy Services (TCS), a global leader in IT services, consulting, and business solutions, 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. This new agentic AI workforce transforms clinical trials and pharmacovigilance services while maintaining regulatory and audit requirements.
Pharmaceutical companies function in highly regulated environments, where they face challenges with 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 to the entire R&D value chain.
TCS ADD™ AgentHub provides a structured framework to mitigate these challenges. Within the framework AI agents can operate with clear roles, defined oversight, and built‑in auditability. Pharma companies can custom build their AI agent hub and deploy them across clinical workflows. The platform allows rapid and streamlined integration with minimal effort, accelerating adoption while maintaining regulatory compliance.
Built on the TCS ADD™ framework, TCS ADD™ AgentHub delivers 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, up to 30% reduction in clinical study build effort through metadata-driven automation, and up to 30% cost savings in end-to-end safety case processing. AI-powered safety agents can also reduce quality control effort by as much as 50%, helping organizations improve productivity across critical R&D processes.
Built on the TCS ADD™ agentic AI architecture, TCS ADD™ AgentHub enables pharma 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 ADDTM AgentHub supports workflows across clinical development and pharmacovigilance through AI workers such as 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. With an evolving catalogue of AI agents to suit specific needs, based on requirements and landscape, they can be deployed progressively, rapidly with minimal integration and implementation effort. By standardizing how AI agents are deployed across these processes, the platform helps organizations improve productivity and focus scientific teams 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.
