Pharmacovigilance (PV) has evolved into a strategic imperative, driven by intensified regulatory scrutiny and an increasing focus on patient safety. Pharmaceutical companies now face a rapidly evolving landscape characterized by rising adverse event volumes, fragmented real-world data sources, and increasingly complex global regulatory frameworks. Regional variations in drug safety reporting requirements further compound compliance challenges across diverse markets. At the same time, the demand for timely and accurate reporting has intensified, particularly as next-generation technologies introduce operational efficiencies while simultaneously raising regulatory concerns regarding the ethical and compliance implications of generative AI in PV. To navigate these complexities, external providers have become indispensable partners, offering deep PV expertise and adaptable support models. These providers bring proven drug safety process frameworks, highly trained PV professionals, and localized regulatory expertise, including qualified persons for PV, ensuring seamless compliance across global markets. Recognizing the need for enhanced efficiency, providers are investing in AI, automation, and advanced analytics to optimize case processing, adverse event management, and signal detection, all while reducing costs and improving operational scalability. In this report, we assess 29 PV operations providers featured on the Pharmacovigilance (PV) Operations PEAK Matrix®. Each provider profile provides a holistic picture of its service focus, solution offerings, and domain investments. The assessment is based on Everest Group’s annual RFI process for calendar year 2024, interactions with leading PV providers, client reference checks, and an ongoing analysis of the PV operations market. Scope Industry: life sciences Geography: global The assessment is based on Everest Group’s annual RFI process for calendar year 2024, interactions with leading PV providers, client reference checks, and ongoing analysis of the PV market Contents This report analyzes 29 providers in detail and includes: Their relative positioning on Everest Group’s Pre-approval Pharmacovigilance (PV) Operations PEAK Matrix® Their relative positioning on Everest Group’s Post-approval Pharmacovigilance (PV) Operations PEAK Matrix® A comparison of their capabilities and market shares Their strengths and limitations

Generative AI can potentially revolutionize the life sciences industry, driving innovation across key areas of the value chain. By streamlining drug discovery, optimizing clinical trials, and enhancing decision-making, it can significantly reduce the time and cost required to bring new medicines to market, setting a new benchmark for industry efficiency and innovation. However, adopting generative AI presents challenges including concerns about data privacy, model accuracy, training resource demands, and ethical implications. As providers work toward addressing these challenges and generative AI becomes a key industry innovation driver, the focus is slowly moving beyond experimental pilot projects to full-scale implementations. This report examines generative AI’s value promise across the life sciences value chain, its market adoption within the industry, and the capabilities of 15 leading providers driving this innovation from pilots to scaled deployment. Scope Industry: life sciences Geography: global The assessment is based on Everest Group’s annual RFI process for the calendar year 2024, interactions with leading life sciences providers, client references, and Everest Group’s ongoing analysis of the life sciences market Contents In this report, we examine Generative AI’s value promise across different segments of the life sciences value chain Its market adoption in the life sciences industry 15 leading providers’ profiles Membership(s) Life Sciences Business Process Life Sciences Information Technology Sourcing and Vendor Management

Gen AI can create diverse content and data formats, revolutionizing the AI landscape and transforming businesses. The pharmaceutical industry can use gen AI to sift through vast clinical data volumes, enabling trial protocols’ drafting and improving clinical trial success rates. In this viewpoint, we present Everest Group’s findings from a survey of 50 pharmaceutical enterprises to evaluate their gen AI expectations, its adoption patterns, and insights into the technology’s role in clinical development. The report offers detailed insights into gen AI’s applications, potential impact, adoption challenges, and best practices to achieve a strategic advantage in the dynamic technology landscape. Pharmaceutical companies can use this report to gain valuable peer perspectives on gen AI, identify essential functionalities when choosing tools/platforms, and understand gen AI’s role in achieving business objectives. Scope Industry: pharmaceutical Geography: global Contents In this report, we: Assess pharmaceutical enterprises’ gen AI objectives Evaluate investment strategies and procurement initiatives to implement gen AI solutions Identify gen AI’s adoption challenges Recommend an enterprise framework to adopt and scale gen AI initiatives Membership(s) Life Sciences Information Technology Sourcing and Vendor Management

Life sciences enterprises are recognizing the strategic importance of selecting the right service providers to enhance their competitive edge in an ever-evolving market. To achieve differentiation, enterprises are seeking partnerships that deliver tangible benefits, such as higher RoI, resilience amid challenging times, robust capabilities, and a distinct market positioning. Notably, enterprises have become more discerning in their partnerships and are seeking providers with a deep commitment to their successes and the credentials and capabilities to back their promises. This report examines the life sciences industry’s sourcing landscape and provides insights for service providers striving to align their offerings with the buyers’ needs and expectations in a dynamic market and amid tight regulatory pressures. Scope Industry: life sciences Geography: global Contents In this report, we examine: Life sciences enterprises’ provider selection criteria Life sciences enterprises’ investment priorities Key outsourcing drivers and challenges Life sciences enterprises’ extent of satisfaction with providers across dimensions Membership(s) Life Sciences Information Technology Life Sciences Business Process Sourcing and Vendor Management

The life sciences industry is rapidly evolving due to macroeconomic shifts, regulatory changes, and increasing competition. These changes have also presented multiple challenges with regard to raw material management, drug efficacy, adherence to safety norms, and patient experience. To overcome these obstacles and seize opportunities, life sciences enterprises need to invest in digital transformation initiatives and scale them to achieve the desired business objectives. However, enterprises often fail to achieve their digital transformation goals and RoI due to inadequate process understanding, resulting in inefficiencies across the life sciences value chain. Therefore, it is important for life science enterprises to understand and optimize their business processes before they implement a new technology solution and scale their digital transformation programs. This report will help life sciences enterprises understand how process mining solutions can help them discover, monitor, and improve their processes to successfully implement transformation initiatives across different stages of the life sciences value chain, such as clinical trials, drug manufacturing, pharmacovigilance, inventory management, and quality control. It also looks at adoption challenges and recommends best practices to drive superior outcomes and position life sciences organizations for long-term success in an ever-evolving industry. Scope All industries and geographies Contents In this viewpoint, we: Examine the life sciences industry’s current state, including key trends and challenges Introduce process mining Discuss process mining adoption in the life sciences industry Understand key barriers and recommend best practices to accelerating process mining adoption Membership(s) Service Optimization Technologies (SOT) Sourcing and Vendor Management

In recent years, the emergence of digital tools and technologies has brought significant change in clinical research and trials. While traditional clinical trials have long been the gold standard for evaluating medical interventions, the proliferation of digital solutions has introduced complexities in managing multiple systems, data silos, and non-interoperable platforms. The patient and sponsor experiences suffer due to the presence of multiple disjointed systems and interfaces, leading to challenges in accessing and managing medical information. These challenges have sparked an urgent need to develop a unified approach that can streamline clinical trials and seamlessly integrate diverse technologies and data sources. The vision of a unified approach to transform clinical trials is fueled by the recognition of these challenges and the understanding that embracing digital technologies alone is not enough. To fully harness the potential of these tools, a cohesive and harmonized ecosystem is required, one in which data flows seamlessly, and technologies complement each other. This viewpoint offers a comprehensive view on a unified platform approach in clinical development, highlighting the key business challenges that enterprises face and the advantages of adopting such platforms. The report also outlines the architecture of these unified clinical development platforms and the benefits they offer to various stakeholders. Additionally, it provides a framework for life sciences companies to transition to this approach and offers recommendations for a successful implementation. Scope Industry: life sciences Geography: global Contents In this report, we present: An overview of a unified platform approach to clinical development including key business challenges that enterprises face and the benefits of adopting such platforms An overview of the architecture of a unified clinical development platform and stakeholder benefits that these platforms can unlock A framework for life sciences enterprises to transition to a unified platform approach and recommendations for success Membership(s) Clinical Development Technology Sourcing and Vendor Management

Clinical trials necessitate extensive planning and involve managing multiple sites, stakeholders, a complicated technology ecosystem, and compliance in a highly regulated environment. Introducing a new drug to the market is a lengthy and laborious procedure that is often accompanied with a significant price tag, averaging around US$2.4 billion. The recent pandemic has significantly influenced clinical trial design and conduct, resulting in a rapid uptake of digital technologies, data science, analytics, and automation tools that improve the efficiency of trial management and workflows. However, the clinical development landscape still has a long way to go, as it remains overly complicated with numerous disconnected systems. This leads to challenges such as data silos, concerns regarding data security and privacy, and the persistence of conventional approaches to data analysis. The unified end-to-end clinical development approach offers a comprehensive solution for efficient trial management that integrates all the necessary solutions for clinical, safety, and regulatory activities with a unified data layer. This approach provides several benefits such as reduced data silos, lower total cost of ownership, and a streamlined product landscape, thereby minimizing the need for integration and custom development activities. This report examines the concept of an end-to-end approach in clinical development, provides insights into current technology implementations, and offers a roadmap for successfully implementing these platforms. Scope Industry: life sciences Geography: global Contents In this report, we: Examine the concept of an end-to-end approach in clinical development Provide insights into the current state of the unification journey Present enterprise expectations from end-to-end clinical development platforms Offer a roadmap for successfully implementing these platforms Membership(s) Life Sciences Information Technology Clinical Development Technology Sourcing and Vendor Management

Labeling and artwork are vital components of the life sciences industry, as they ensure regulatory compliance and can be used in packaging, online, and in the supply chain. Failure to comply with Good Manufacturing Practice (GMP) requirements, which include proofreading and change control, can lead to errors in labeling content, resulting in significant fines and drug recalls. In this viewpoint, we examine the evolving labeling and artwork landscape for the biopharmaceutical and medical device industries, current market trends, and the provider landscape, along with possible synergies. Industry Life Sciences BPS Geography Global Contents In this report, we examine: The evolving labeling and artwork landscape for biopharma and medical devices industries Current market trends The provider landscape and possible synergies Membership (s) Life Sciences Business Process Sourcing and Vendor Management

The rising burden of chronic diseases worldwide is driving life sciences companies’ drug development efforts. These drug development efforts need to abide by the strict drug safety regulations of public health organizations, such as the US Federal Drug Administration (FDA) and the European Medicines Agency (EMA). The regulatory protocols mandate the prior- and post-marketing safety assessment of drugs and are increasingly pressing biopharma and medical device companies to effectively capture, assess, and monitor Adverse Events (AEs) to gain the trust of both regulators and consumers. In this viewpoint, we focus on the challenges that face the US$19 billion Pharmacovigilance (PV) market amid increasing AEs and changing regulations. We also look at the measures that life sciences enterprises have adopted in tackling these challenges, including partnering with third-party providers for technology solutions. Industry Life Sciences BPS Geography Global Contents This report provides a detailed analysis of the PV landscape, including: Emerging challenges for life sciences enterprises Enterprise adoption of point solutions The role of third-party providers Current state of the PV market Membership (s) Life Sciences Business Process Sourcing and Vendor Management

The Pharmacovigilance - Complaint Management Operations - Service Provider Compendium – provides accurate, comprehensive, and fact-based snapshots of 22 pharmacovigilance and complaint management service providers. It presents providers’ scale of operations, technology solutions, and delivery locations, along with Everest Group’s PEAK Matrix® service provider assessment. The compendium also sheds light on the global pharmacovigilance and complaint management service provider landscape The study will enable existing and potential buyers of pharmacovigilance and complaint management operations to assess the providers on their strengths and limitations based on desired capabilities Scope The report evaluates 22 pharmacovigilance and complaint management operations service providers: Accenture, Cognizant, Covance, IQVIA, TCS, Wipro, APCER Life Sciences, Atos, Bioclinica, ICON plc, Indegene, Navitas Life Sciences, Parexel, PharmaLex, PPD, PRA Health Sciences, PrimeVigilance (Ergomed plc), Syneos Health, HCL Technologies, Medpace, Quanticate (Qvigilance), and Tech Mahindra Contents Each service provider profile captures the following details Service suite and scale of operations: key leaders, services suite, FTEs, revenue, recent developments, and partnerships Delivery locations: city-level detail of key delivery locations worldwide Capabilities and clients: major engagements, revenue split by geography, FTE split by process coverage and location, and number of contracts by buyer size Technology solutions: brief descriptions of key technology solutions Everest Group assessment: service provider’s position on the Everest Group PEAK Matrix®, market share and delivery capability assessment, and overall evaluation of service provider capabilities Membership Life Sciences Business Process Sourcing and Vendor Management