Industry
Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- Patient centricity, increased regulatory scrutiny, complex diseases, and the need for next generation treatment, are key trends shaping pharmacovigilance (PV).
- Biopharma companies must focus on harmonising global and local PV functions, addressing interoperability issues, and rationalising siloed processes.
- AI-assisted case processing, evidence synthesis, and signal prioritiszation support faster, more consistent safety evaluations.
- TCS combines these capabilities with PV domain expertise, risk-based validation, and human oversight, retaining expert accountability for critical safety and medical decisions.
On this page
Overview
The pharma industry constantly aims to meet regulatory compliance to accelerate the delivery of life-changing medicines to patients.
The industry faces varied challenges, including adverse event (AE) volume management, and complying with evolving regulations, while rationalising costs. Besides, developing novel drugs such as monoclonal antibodies (mAbs), RNA vaccines, and combination products calls for heightened safety scrutiny. AI-assisted triage, developing intelligent workflow orchestration, and data-driven prioritisation can help address these pressures while maintaining expert oversight.
Increased awareness and knowledge are needed to evaluate real-world evidence (RWE) sources for signals and safety information. The challenge is finding efficient and cost-effective and responsible AI solutions that can extract insights from diverse safety data while supporting transparent, human-led decision-making.
Biopharma companies need scalable and flexible PV operations. AI-enabled automation, knowledge mining, and advanced analytics can further connect these capabilities and support timely, consistent safety decisions.
Our solution
Our AI-enabled PV services combine deep domain expertise, medico-scientific judgment, intelligent automation, and analytics to strengthen regulatory compliance, and enhance quality and efficiency.
We have established a value-focused metrics framework to measure quality, compliance, productivity, automation effectiveness, and the impact of AI-assisted decision support.
The focus areas of the TCS Pharmacovigilance Services portfolio include:
- End-to-end individual case safety reports (ICSR), literature surveillance, regulatory intelligence, aggregate writing, signal detection and management, medical safety, and risk management. This is further supported by AI-assisted intake, triage, duplicate detection, coding, narrative generation, review prioritization, and safety insights generation.
- Local affiliate activities (case intake, submissions, literature, and follow-up), PV analytics, and applications, with multilingual AI support, intelligent routing, predictive workload planning, and analytics-enabled compliance monitoring.
- Support customers for SOP management, Pharmacovigilance system master file (PSMF) maintenance, safety data exchange agreement (SDEA), learning management, MedDRA update support, Extended EudraVigilance medicinal product dictionary (XEVMPD) support, and compliance management. This is augmented through AI-enabled knowledge retrieval, document intelligence, impact assessment, and monitoring.
Figure 1: Combining deep PV domain capabilities with cognitive automation and AI
We adopt the following approaches to ensure regulatory compliance –
Domain-led AI approach: Our flexible, scalable, and knowledge-enriched PV operations harmonize global (ISO IDMP, RMP, electronic submissions) and local PV functions. Our consultants keep abreast with evolving regulations (ICH E2B-R3, EU CTR, GVP VI-Rev 3) and engage with customers to develop innovative fit-for-purpose AI use cases. They strategise, define, approaches, and establish validation and oversight controls. With their thorough knowledge of the product and disease, our PV professionals focus on quality and compliance ensuring and our teams are always audit-inspection-ready. They apply human judgment to AI-generated recommendations and maintain decision traceability.
Intelligent Automation approach: Our AI-enabled PV services automate safety data collection across patient, physician, and digital channels. Intelligent workflows, predictive analytics, and expert review support efficient ICSR processing and signal monitoring. Risk-based validation, human-in-the-loop review, data privacy controls, performance monitoring, and clear accountability enable responsible deployment.
Benefits
We offer PV services for life-changing medicines that create long-lasting value for patients and society.
We provide continuous support in safety evaluations for revolutionary medicines—gene therapy, cell therapy, pharmacogenomics, real-world data, and digitized clinical trials—with a vision for a healthier world for everyone.
AI-assisted evidence synthesis, pattern recognition, and knowledge mining help our experts evaluate complex and diverse safety information with greater speed and consistency,
Key benefits include:
- Modernising PV operating models through responsible AI governance, controls, validation and human oversight
- Employing predictive PV—using AI-assisted data analytics, signal monitoring, pattern detection, and risk identification—for faster risk identification evaluations
- Strengthening regulatory submissions through intelligent workflow monitoring, automated quality checks, and proactive exception management
- Defining customer processes and regulatory guidance documents, supported by AI-enabled regulatory intelligence, document comparison, and impact assessment
- Devising global location strategy for country-specific requirements, supported by AI-enabled workload forecasting, capacity planning, and robust business continuity planning
THE STORY IN NUMBERS
The TCS advantage
TCS has been regarded as the industry leader in providing pharmacovigilance services by several market data analysts.
Since two decades, our strategic and long-standing PV partnerships have expanded to niche PV services, and we added new delivery locations and new talent. Our expertise in the PV domain and medico-scientific acumen, coupled with the successful deployment of AI, has won the trust of leading pharma companies.
We offer the following differentiators:
- Our PV services have been inspected, audited, and accredited by worldwide regulatory health authorities with a proven track record of zero critical findings
- Our Pharma Academy of Learning and Sharing (PALS) team has created robust training modules that build PV expertise, AI literacy, responsible-use practices, and effective human-AI collaboration
- Our multi-location delivery model offers combines global PV talent, AI-enabled workload orchestration, cost-effectiveness and excellent time zone coverage so you always meet the regulatory timelines
How we helped our customers
The end-to-end PV transformation journey of a large UK-based pharma company
Multiple hand-offs at customer's regional centers led to delays and high oversight. The customer needed a different approach to manage large case volumes with high quality and 100% compliance.
We helped the customer merge its fragmented and disparate processes across various regional centers, achieve 100% ICSR delivery, identify gaps and streamline training, and reduce the need for process supervision. We consolidated the customer’s seven regional centers into three regions by charting a global unification strategy and updating the customer’s relevant SOPs and guidelines. The transformed model created the foundation for AI-assisted intake, workload prioritisation, quality checks, compliance monitoring, and knowledge-driven operations.
Our PV services enabled the customer to achieve the following:
- Synergistic PV operations and harmonized global processes in ICSR
- Streamlined processes pertaining to aggregate reports, safety surveillance, and signal detection
- High quality and regulatory compliance owing to the implementation of industry-benchmarked SLAs and KPIs
In conjunction with our PV domain services, the adoption of the TCS ADD™ Safety platform and its AI-enabled capabilities led to significant efficiency gains for ICSR intake and case processing steps. Intelligent data extraction, duplicate detection, coding assistance, narrative drafting, workflow prioritisation, and quality checks supported faster and more consistent processing, with expert review retained for safety-critical decisions. We also engaged with the customer’s teams to offer functional consulting for new signal system development, including analytics-enabled signal prioritisation and implementation.
A large UK-based pharma customer required highly experienced physicians (including medical review)
We deployed experienced safety physicians to support early-development and post-marketed products. Major activities included reviews and/or authoring of signal evaluations, preparations of signal evaluation reports, medical evaluations of ICSRs from clinical trials (SUSARs), line listing preparations, aggregate analyses, analysis of similar events, supporting investigator, and investigational new drug safety reports (INDSR) notifications, signal management team (SMT), reviews, reviewing aggregate reports, risk management plan (RMP) reviews, participate in label committee meetings for potential label changes, preparation of health authority responses, benefit-risk evaluations and support to cross-functional teams in clinical and regulatory activities.
These safety physicians act as clinical trial safety physicians as well and review study protocols, investigator brochures (IBs), electronic case report forms (eCRFs), clinical development plans, clinical study reports (CSRs), and health authority (HA) submissions. This team works closely with the ICSR medical review team.
Once the project started, our physicians required minimal to no supervision. Medico-scientific knowledge exchange and high collaboration between our safety physicians and customers’ physicians for product safety enabled faster evaluations and timely decision-making.