Showing 10 results
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May 07, 2025Increasing trial complexity, growing data volumes, and the rise of decentralized and real-world data sources are fundamentally transforming the clinical trial landscape. Traditional Clinical Data Management (CDM) processes are largely manual and rely on siloed data systems, making them inefficient and error-prone. In response, AI is emerging as an essential force in reshaping CDM. This Viewpoint analyzes the transformative roles of AI, generative AI and agentic AI, in modernizing CDM operations. It details how AI is enabling intelligent automation across the trial lifecycle, from protocol design and CRF setup to real-time data validation, anomaly detection, and regulatory documentation. Agentic AI is further pushing boundaries by enabling adaptive, autonomous decision-making with minimal human intervention. These capabilities not only reduce cycle times and improve data quality but also fundamentally shift how clinical teams manage, interact with, and derive insights from data. The report also offers a landscape view of AI-powered solutions across provider types, including global CROs, specialist CDM firms, and IT/BPO players. It outlines key cases, priority capabilities, and practical considerations for life sciences enterprises looking to integrate AI into their CDM strategies. Industry Life Sciences BPS Geography Global Contents In this report, we examine: The limitations of traditional CDM models in an increasingly complex data environment The role of AI, generative AI, and agentic AI in transforming CDM operations Key use cases across the CDM value chain The provider landscape, including differentiated value propositions across CROs, IT/BPO firms, and niche players Future outlook on multi-agent collaboration, autonomous compliance, and intelligent patient engagement through agentic AI Strategic considerations for evaluating and implementing AI-powered CDM solutions Memberships Clinical Development Technology Life Sciences Business Process Sourcing and Vendor Management
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State of the Market
Creating Value with a Purpose: Impact Sourcing State of the Market 2024
Dec. 27, 2024The impact sourcing ecosystem is rapidly expanding due to the growing interest in sustainable and socially responsible business practices. Enterprises and providers are increasingly incorporating diverse and underserved talent into their operations due to cost efficiency, access to specialized talent, and alignment with ESG and SDG objectives. Traditional providers dominate hiring volumes, while specialists see steady growth in revenue and headcount as they refine talent initiatives and partner with NGOs and educational institutions. Buyers recognize the dual value of cost benefits and corporate citizenship, advocating for more robust reporting and impact sourcing policies’ disclosure. In response, providers are investing in enhanced training programs, certifications, and technology upskilling, enabling impact workers to transition to more complex, higher-value roles. Despite generative AI’s disruptive potential concerns, agentic AI emerges as a promising tool to empower the impact workforce. Key market trends include the CXM industry’s increasing contribution to impact sourcing revenue, growing adoption of impact workers in MEA and APAC regions, and alignment with regulatory frameworks promoting fair labor practices. Governments support impact sourcing through incentives and regulations, while providers adopt inclusive hiring strategies and offer tailored employee support to complement workforce diversity and drive social impact. In this report, we explore macroeconomic drivers, buyer feedback, and generative AI’s influence on the impact sourcing space. Africa stands poised to lead the global impact sourcing growth, showing this approach’s transformative potential in fostering a purpose-driven and sustainable business landscape. The report aims to enable enterprises and providers to incorporate impact sourcing and other inclusive talent management strategies in their organizations. Scope Broad industry with a focus on impact sourcing talent strategy Geography: global Impact sourcing programs of both impact sourcing specialists and traditional service providers This report is based on primary and secondary data collection, conversations with market participants (buyers, outsourcing service providers, and impact sourcing specialists), and fact-based research Contents In this report, we analyze: The concept of impact sourcing and the comprehensive impact sourcing market landscape, including market size, trends, and talent portfolio Impact sourcing’s talent management practices across the hire-to-retire cycle Buyers’ take on impact sourcing Impact sourcing engagement case studies Technology’s role on the impact sourcing market and the future of impact sourcing programs Memberships This Market Report is available to All Memberships
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July 03, 2024Gen 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
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Thematic Report
Optimizing Clinical Development RoI: Trends, Challenges, and Opportunities in Patient Recruitment
June 20, 2024Patient recruitment is a complex and dynamic part of clinical trial management, requiring proactive strategies, collaborations, and innovation to overcome challenges and achieve enrollment targets. Patient recruitment is vital for clinical trials, yet it presents challenges that impact study timelines, costs, and overall success. By adopting patient-centric approaches, using technology, and fostering collaborations across stakeholders, organizations can enhance recruitment efficiencies and accelerate study timelines, ultimately introducing new treatments to market faster for patients’ benefit worldwide. Patient recruitment in clinical trials will evolve due to technology advances, changing regulatory landscapes, and dynamic patient expectations. Outsourcing patient recruitment to specialized firms offers enterprises and Contract Research Organizations (CROs) opportunities to use expertise, scalability, and flexibility in navigating enrollment complexities. In this report, we examine the patient recruitment landscape, including the challenges that sponsors face. The report also assesses the current state of the supplier ecosystem and explores technology’s role in solving major challenges in patient recruitment. Scope Industry: life sciences Geography: global Services: life sciences BPS, life sciences ITS, and clinical development technology Contents In this report, we: Examine the patient recruitment landscape, including the challenges that sponsors face The report also assesses the current state of the supplier ecosystem and explores technology’s role in solving major challenges in patient recruitment Membership(s) Life Sciences Business Process Sourcing and Vendor Management
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June 03, 2024The evolving regulatory landscape poses significant challenges for life sciences enterprises. Enterprises struggle to navigate complex compliance frameworks, stay updated with emerging regulations, and manage diverse geographical requirements, all vital for achieving regulatory compliance and securing market access. As a result, enterprises are seeking providers with specialized knowledge and technology expertise to efficiently manage these intricate regulatory landscapes. In response, providers are enhancing their capabilities and offerings by investing significantly in technology. They are expanding their portfolios to include innovate tools and platforms to streamline regulatory processes. Additionally, to provide enhanced value and accessibility, providers are increasing their global presence by establishing localized support networks to cater to the nuanced requirements of diverse markets. In this report, we assess 20 providers featured on the Regulatory and Medical Affairs Operations PEAK Matrix®. Each profile offers a comprehensive picture of the provider’s key strengths and limitations. Scope Industry: life sciences Geography: global This report is based on Everest Group’s annual RFI process for calendar year 2024, interactions with leading regulatory and medical affairs providers, client reference checks, and an ongoing analysis of the regulatory and medical affairs Business Process Services (BPS) market Contents In this report, we: Position the providers on Everest Group’s PEAK Matrix® as Leaders, Major Contenders, and Aspirants Compare providers’ capabilities and market shares Assess providers’ key strengths and limitations Membership(s) Life Sciences Business Process Sourcing and Vendor Management
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Viewpoint
A Unified Approach to Clinical Trials
Nov. 08, 2023In 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
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Oct. 31, 2022Remote Patient Monitoring (RPM) is an integrated approach that employs technology-backed medical devices to gather physiological and biometric data from patients that is electronically transmitted for remote analysis, review, and, when necessary, interventions and preventive care. Advances in network technologies, connected devices, medical wearables, sensors, data analytics algorithms, and software are paving the way for efficient data collection in remote clinical trials and the delivery of advanced healthcare. Traditionally, patients had to physically arrive at hospitals or research centers to participate in clinical trials. However, the pandemic and the lockdowns that followed compelled the industry to come up with innovative ways to collect patient data. Decentralized Clinical Trials (DCTs), based on remote data collection and timely data analysis, proved to be indispensable to the clinical research industry over the last two years. As the industry emerges from the pandemic, organizations will continue to accelerate DCT adoption and convert piecemeal deployments into a comprehensive strategy. This report examines the present state of RPM in decentralized trials, the drivers and challenges facing RPM, and the future state of RPM, as well as shares an approach to successfully implement an RPM solution. Scope Industry: life sciences Geography: global Contents In this viewpoint, we: Examine the present state of RPM Evaluate the drivers and challenges for RPM Share the future outlook for RPM Provide a roadmap for the successful implementation of an RPM solution Membership(s) Life Sciences Information Technology Sourcing and Vendor Management
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Sep. 30, 2022The 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
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PEAK Matrix®
Pharmacovigilance and Complaint Management Operations – Services PEAK Matrix® Assessment 2021
March 19, 2021Traditionally considered to be a cost-function by life sciences enterprises, the pharmacovigilance and device-vigilance / complaint management market is finally getting its long-due attention from all industry sections – including regulatory agencies, drug safety teams, and media. This attention stresses on the need to effectively monitor drugs/devices and prioritize patient safety. The enterprise community is pursuing strategic technology investments and realigning its focus on value-added drug safety activities while outsourcing case processing to third-party service providers. Service providers – CROs, IT/BPOs, and product safety specialists – are helping enterprises address these challenges by providing well-established drug/device vigilance processes/services, offering staff augmentation capabilities with access to highly trained resources, and supporting the regional QPPV activities. Notably, the service provider community is investing in technology IP across pharmacovigilance / complaint management activities to improve efficiency, reduce costs, manage volumes, and remain compliant. The pharmacovigilance and complaint management market has reached an inflection point, and these process- and technology-driven investments will start paying off in the coming years, as both the parties try to achieve more with less. In this research, we present an assessment and detailed profiles of 22 service providers featured on the Pharmacovigilance and Complaint Management Operations – Services PEAK Matrix®. Scope Function: pharmacovigilance and complaint management business process services Industry: life sciences BPS Geography: global Companies evaluated: 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, Medpace, Quanticate (Qvigilance), Tech Mahindra Contents This report provides detailed profiles and assessments of 22 operations service providers featured on Everest Group’s Pharmacovigilance and Complaint Management Operations – Services PEAK Matrix®. Each service provider profile provides a comprehensive picture of its service focus, key IP/solutions, domain investments, and case studies. Membership Life Sciences Business Process Sourcing and Vendor Management
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Viewpoint
Increasing Diversity in Clinical Trials
Oct. 16, 2020The evidence and insights from clinical trials form the backbone of care delivery, as regulatory bodies use them to approve drugs and physicians use them to decide clinical interventions and make prescription decisions. In an ideal world, clinical trials would have adequate representation from all sections of the population, regardless of ethnicity, gender, geographical location, and socioeconomic status, to ensure robust evidence for all population groups. But, in reality, clinical trial populations are significantly less diverse than the actual population the medicines are intended to treat. Though the life sciences industry acknowledges this lack of diversity in clinical trials, there has not been significant progress to address this important issue, beyond pockets of excellence in limited clinical studies. This viewpoint examines the barriers to increase diversity in clinical trials, initiatives needed to plug the diversity gaps, technology interventions required in the clinical development value chain to improve the scenario, the role of virtualized trials in addressing various diversity barriers, and the implications and next steps for various stakeholders to achieve diversity in clinical trials. Scope Industry: life sciences Geography: global Contents In this viewpoint, we discuss the following topics: The current state of diversity in clinical trials Challenges with diversity initiatives today A technology framework to increase diversity in clinical trials Preparing a blueprint for success Focusing on the journey Membership(s) Life Sciences Information Technology Sourcing and Vendor Management
