TCS launches agentic AI platform for clinical trials and drug safety workflows

Indian IT services major Tata Consultancy Services (TCS) has launched an enterprise agentic AI platform aimed at helping pharmaceutical companies automate clinical development and drug-safety processes while meeting regulatory, governance and audit requirements.

Called TCS ADD AgentHub, the platform allows pharmaceutical companies to build and deploy role-based AI agents across clinical trials and pharmacovigilance workflows. It is designed to operate through a “human plus AI” model, in which agents perform defined tasks while people retain oversight and responsibility for decisions.

The launch comes as pharmaceutical companies explore the use of artificial intelligence to manage growing research data volumes, accelerate clinical studies and automate repetitive processes. Adoption, however, remains constrained by fragmented technology systems and concerns about the reliability, traceability and regulatory compliance of AI-generated outputs.

TCS said AgentHub provides AI agents with clearly defined roles, oversight mechanisms and built-in auditability. The platform can be integrated with existing pharmaceutical systems and allows companies to introduce agents progressively across different processes instead of attempting an enterprise-wide deployment at once.

TCS claims solutions powered by the platform have demonstrated efficiency improvements of up to 40% in clinical data-management activities. Metadata-led automation can reduce the effort required to set up clinical studies by up to 30%, while the automation of end-to-end safety-case processing can generate cost savings of up to 30%, according to the company.

AI agents performing quality-control tasks in drug-safety operations can reduce the associated manual effort by as much as 50%, it added. TCS did not disclose the customers or number of deployments from which these estimates were derived.

The platform supports drug-safety workflows including individual case safety report intake, data entry, medical coding, review and scientific literature analysis.

Within clinical development, its agents can assist with study design, converting clinical protocols into structured digital formats, reviewing clinical data, medical monitoring and transforming data into the Study Data Tabulation Model—a standard used when submitting clinical trial information to regulators.

By standardising how AI agents are introduced across these workflows, TCS expects the platform to reduce implementation effort and allow scientific and clinical teams to focus on work requiring domain expertise and human judgement.

“TCS ADD AgentHub will enable our customers to accelerate drug development using agentic AI at scale,” said Debashis Ghosh, president of lifesciences and healthcare at TCS. “It enables a shift from reactive to proactive, scalable and audit-ready operations amid an ever-changing regulatory environment.”

Ghosh said TCS is working towards more autonomous enterprise functions in which AI agents operate alongside employees to support drug development and patient safety.

AgentHub is built on TCS ADD, the company’s suite of software products for clinical research and drug development. TCS said the platform contains an expanding catalogue of agents that can be configured according to a pharmaceutical company’s processes and technology environment.

The company has been expanding its AI portfolio as it seeks to position itself as an AI-led technology services provider. The latest launch targets an area where the potential for automation is significant but deployment requires stricter safeguards than in general-purpose enterprise applications because AI outputs can affect regulatory submissions, clinical decisions and patient safety.

While AgentHub can automate defined steps and provide recommendations, responsibility for governance and final decision-making will continue to rest with human specialists, TCS said.