TCS ADD™ AgentHub
AI workforce for drug development
Products and Platforms
TCS ADD™
TCS ADD™: A Suite of Modern and Open Technology Platforms
Highlights
- To meet the need for secure, compliant data synthesis, we developed our flagship, cloud-native platform, TCS ADD™. This platform enables digital ecosystems, simplifies data complexity, and drives innovation in clinical trials to accelerate drug development.
- Built on this foundation, TCS ADD™ AgentHub introduces a new operating model for applying AI in regulated drug development processes: an enterprise ready AI workforce designed for clinical development and pharmacovigilance work.
- TCS ADD™ AgentHub brings together role based AI agents aligned to how regulated work is performed — with defined responsibilities, supervision, human accountability, and auditability built in by design.
Overview
Scale agentic AI into inspection-ready, governed GxP operations, fast.
Life sciences organisations continue to face growing data volumes, fragmented systems, and increasing regulatory expectations across clinical development and pharmacovigilance.
While AI pilots and copilots are now common, many struggle to scale these initiatives into inspection ready, repeatable operations. In regulated environments, intelligence alone is not the limiting factor. Governance, accountability, and lifecycle control are what determine whether AI can be trusted and scaled for core GxP workflows.
TCS ADD™ is a suite of modern, open platforms designed to simplify this complexity and enable digital ecosystems that accelerate the delivery of medicines to patients. Leveraging agentic AI, TCS ADD™ transforms clinical trials and regulatory processes. We are pivoting from traditional, isolated AI use cases to interconnected, orchestrated systems that enhance human-machine collaboration and drive autonomous operations.
Welcome to TCS ADD™ AgentHub, our AI workforce for drug development that is role based, enterprise ready and trusted.
Our solution
Role-based AI agents for governed, audit-ready execution across GxP workflows
TCS ADD™ AgentHub shifts the mental model from isolated tools to an AI workforce. Instead of treating AI as a collection of assistants or scripts, TCS ADD™ AgentHub structures AI as role based workers that participate in work much like human team members:
- Defined responsibilities and scope
- Supervision and review by humans
- Measurable performance (quality, throughput, and compliance)
- Built in audit trails and lifecycle control
This model supports assistive, co pilot, and controlled autonomous modes, allowing organisations to start small and progress at a pace aligned with their regulatory comfort and operating maturity.
TCS ADD™ AgentHub includes agents for clinical development and pharmacovigilance (PV) as outlined below in the three modes:
Clinical Development Agents
Clinical Development Agents
Listed below are few of the AI agents for Clinical development available through TCS ADD™ AgentHub:
- Study design optimiser assistant
- Study setup assistant/protocol digitisation agent
- Clinical data review worker
- SDTM transformation worker
- Medical monitoring assistant
- Reasoning and acting (RACT) agent and monitoring artefact generators
These roles focus on augmenting human decision making, not replacing clinical accountability.
Pharmacovigilance Agents
Pharmacovigilance Agents
Listed below are few of the AI agents for Pharmacovigilance available through TCS ADD™ AgentHub:
- ICSR receipt worker
- ICSR intake worker
- ICSR data entry worker
- Medical coding assistant/worker
- Medical review assistant
- Quality review assistant
- Literature analysis worker
Each role is aligned to existing PV responsibilities and designed to operate with human oversight and audit-readiness.
The benefits of our solution
Scalable, compliant AI operations with human oversight and progressive autonomy
The TCS ADD™ AgentHub has several benefits, some of which are given below:
Scalable outcomes
Scale execution to address spikes in business demand, without linear headcount growth by using AI workers for repeatable, high volume tasks while keeping humans focused on review and judgement.
Quality and compliance by design
Human in the loop controls, auditability, explainability, and GxP oriented governance are embedded into how AI workers operate.
Progressive autonomy
Adopt AI safely through assistive and co pilot modes first, with clear governance pathways toward higher levels of automation where appropriate.
Focus on higher value work
Reduce manual effort and rework so clinical and safety professionals can focus on complex scientific and medical decision-making and oversight.
The TCS differentiation or advantage
Built for regulated scale: role-based AI, governed autonomy, and flexible adoption models
TCS ADD™ AgentHub is designed as a governed operating system for AI workers in regulated life sciences.
Key differentiators include:
- Role based AI for clinical and pharmacovigilance, aligned to real operating models
- Human governed autonomy, with supervision, review, and audit built in
- Lifecycle and change control, supporting safe updates and inspection-readiness
- Flexible adoption models, allowing organisations to adopt this model as:
- Embedded AI copilots
- AI worker as a service
- Bring your own agent within a governed framework
- Proven expertise: TCS has been a pioneer in AI for the drug development landscape and has implemented at scale robust, production-ready AI products for the highly regulated demands of drug development
This approach allows organisations to start with one role, prove value, and progressively expand across workflows with confidence.