The changing economics of pharmacovigilance services
For years, the life-sciences operating model relied on a network of specialized partners. Pharmaceutical companies retained responsibility for their products, safety oversight and regulatory obligations, while CROs delivered PV operations, technology consultants implemented and supported safety systems, and hosting partners managed the underlying infrastructure.
These roles often overlapped, but their boundaries were relatively distinct. Today, they are becoming less clear.
Pharmaceutical companies are building deeper capabilities through Global Capability Centres (GCCs). CROs are expanding into technology products and platforms. Companies traditionally focused on implementing or hosting established safety databases are developing proprietary solutions, while specialist PV providers are turning domain expertise into products. AI-native entrants are targeting individual workflows with generative AI and automation.
The result is a changing competitive landscape in which services, technology and in-house capabilities increasingly intersect.
GCCs: No longer just delivery centres?
Pharmaceutical companies are expanding GCC capabilities beyond traditional support functions into specialised operations, technology, analytics and innovation.
Novo Nordisk has also established a Bengaluru GCC with broad capabilities spanning pharmacovigilance (manages roughly 75% of global pharmacovigilance caseload), regulatory reporting, clinical data management and other global functions. Sanofi is expanding its Hyderabad GCC, while Eli Lilly is growing its Indian capabilities in AI, automation and software engineering. Bristol Myers Squibb has established a Hyderabad innovation hub focused on drug development and digital capabilities, and Takeda has been exploring expanded GCC capabilities in AI, data science and digital health.
For PV, this could translate into greater in-house ownership of selected safety operations, analytics, system support and automation. This shift may change which activities pharmaceutical companies choose to retain internally and which they continue to source externally.
CROs and specialist PV providers: From services to technology
CROs are increasingly combining operational delivery with proprietary technology and AI. IQVIA’s Vigilance Platform supports safety case management and reporting, while ICON offers tools such as ORCA Safety and Signet for safety monitoring and signal visualisation. PPD combines PV services with its SafetyNet Suite, Syneos Health has developed PV Hub and a generative AI-enabled case-intake solution, and Parexel’s acquisition of Vitrana brought technology capabilities, including HiLIT, into its patient safety portfolio.
Specialist providers are following different paths. Continuum, a life-sciences services company spanning PV, health economics and outcomes research (HEOR), and regulatory affairs, is diversifying into products such as COLMAP for literature management, ARINA for aggregate reporting and COSMAP for signal management. ACI and HAROM have also expanded from PV services and training into technology, including HAROM Safety Vault.
Meanwhile, Nextrove, RxLogix and Ultragenic, which have built capabilities around the implementation, hosting and support of established safety platforms such as Oracle Argus and Veeva, are also developing proprietary PV technology solutions.
These examples illustrate how some PV providers are extending their domain expertise beyond traditional service delivery through proprietary software, specialised applications and technology-enabled workflows.
AI-native entrants: Targeting specific PV workflows
A new category of companies is developing AI-focused tools for individual pharmacovigilance activities. Yeza.ai focuses on AI agents for safety intake, triage and E2B generation; Graph Safety (GraphAI) is developing an AI-oriented patient safety platform; DrugCard applies AI to literature monitoring and regulatory intelligence; and Pivot Path, through its NovaVigil platform, targets workflows including literature monitoring, case intake and signal detection.
Their capabilities and maturity differ, but these examples illustrate how new entrants can target specific PV workflows without necessarily building an entire safety database.
Generative AI: Will it change the economics of building PV products?
Generative AI may make it easier to experiment with specialised tools for ICSR intake, literature screening, quality checks, regulatory intelligence and other PV workflows. Domain experts could potentially collaborate with technology specialists to develop focused solutions without undertaking the same scale of software development traditionally required.
However, lower barriers to experimentation may not automatically translate into lower deployment costs or sustainable business value. A working prototype is very different from a validated, secure and reliable solution operating in a regulated environment.
The real test will be performance in production: how well tools handle real-world safety data, integrate with existing workflows, maintain output quality and scale, and reduce costs after accounting for human review, validation and ongoing maintenance. Adoption will ultimately depend on demonstrable efficiency gains and cost-effectiveness, not projections or successful pilots alone.
A competitive squeeze—or a reshaping of the market?
As GCCs build internal expertise, pharmaceutical companies may retain greater control over selected operations, technology strategy, analytics and automation. External service providers may increasingly be engaged for specialised expertise, complex workloads, implementation support and flexible capacity.
Technology providers could face similar shifts as clients customise established platforms, build internal tools and develop their own automation. Rather than eliminating external vendors, this may change expectations around integration, specialised functionality and the value delivered beyond the software itself.
The future may not be a simple choice between insourcing and outsourcing. Hybrid models could emerge in which GCCs own strategy and critical capabilities, technology partners provide platforms and specialist solutions, and service providers deliver expertise and flexible execution.
In this environment, providers that combine strong PV domain knowledge with technology capabilities may have an advantage. Their ability to translate expertise into integrated solutions could become an important differentiator, provided they can demonstrate measurable value and reliable performance in real-world settings.
For PV service providers, the strategic question is therefore not simply how to compete with increasingly capable clients, but where external expertise can complement internal capabilities most effectively.
Disclaimer: The companies and examples mentioned are illustrative, not exhaustive, and represent a selection of developments across the PV services and technology landscape. Product capabilities and maturity may change over time; specific offerings should be verified with the respective providers.