TCS Brings Audit-Ready Agentic AI to Global Drug Development

In drug development, the race to bring life-saving therapies to patients is often held back not by scientific discovery, but by operational complexity.

In highly regulated environments, pharmaceutical companies must maintain rigorous auditability at every stage, creating a delicate balance between harnessing AI’s potential and meeting the strict demands of regulatory compliance.

Tata Consultancy Services (TCS) is seeking to bridge this gap with AI agents designed to operate within the stringent audit, governance and compliance requirements of clinical operations.

Its TCS ADD AgentHub platform is designed to help life sciences organisations scale the use of AI while maintaining human oversight and regulatory control.

Agents designed for clinical work

The platform is built on the TCS ADD suite and uses what the company calls AI Workers, Assistants and Tools. These handle tasks such as case intake, medical coding, quality review, literature analysis and study support.

According to TCS, each AI action occurs within a framework of human oversight and lifecycle control. The model is role-based and structured to operate alongside human experts rather than replace them.

"TCS ADD AgentHub introduces a role-based AI workforce that supports key drug development functions across pharmacovigilance and clinical operations," says Rachna Malik, Global Head of TCS ADD. "These agents perform specialised tasks while operating within a framework of human oversight, governance, auditability and lifecycle control."

Rachna notes the intention is not to replace medical and scientific professionals but to reduce the time they spend on repetitive tasks. 

"Compared with traditional human-led processes, AgentHub helps organisations scale operations, reduce repetitive manual effort, improve consistency and enable experts to focus on higher-value scientific and medical decision-making."

Performance metrics from clinical deployments

TCS reports that measurable outcomes from platform deployments have already been demonstrated. According to the company, AgentHub has delivered up to 40% efficiency gains in clinical data management activities.

Other results include up to 30% reduction in clinical study build effort through metadata-driven automation. The company also cites up to 30% cost savings in Individual Case Safety Report processing.

These outcomes stem from earlier enterprise deployments of AI in production environments.

"A lot of our learnings have come from the large-scale deployment of earlier generations of AI in production, directly addressing past shortcomings in value realisation," Rachna says.

She adds that solutions available through AgentHub could accelerate trial setup and submission timelines. "Key solutions available through AgentHub accelerate trial setup and submission timelines, where the business impact is highest."

Human oversight in regulated environments

AgentHub's technical architecture of AgentHub is collaborative. Intelligent agents manage embedded workflows while human clinical professionals retain final control over medical and regulatory decisions.

According to TCS, this model could provide pharmaceutical companies a way to scale clinical operations while managing compliance risk. The company says the approach is designed for environments where auditability is mandatory.

"TCS ADD AgentHub is an enterprise-ready, trusted AI platform that enables our customers to accelerate drug development using agentic AI at scale," says Debashis Ghosh, President of Life Sciences and Healthcare at TCS. 

"It enables a shift from reactive to proactive, scalable and audit-ready operations amidst an ever-changing regulatory environment."

Debashis adds that the company's strategy is to move toward what it calls autonomous enterprise functions. "TCS's strategy is to move toward autonomous enterprise functions where an AI workforce operates alongside humans to drive innovation and improve patient safety."