Clinical trial complexity continues to increase with hybrid study models, diverse data sources, and growing regulatory expectations, making traditional oversight models inadequate. Conventional monitoring approaches reliant on 100% source data verification and frequent on-site visits are costly, inefficient, and reactive, often identifying issues too late in the process. Risk-based Quality Management (RBQM) offers a proactive, data-driven approach by embedding continuous risk assessment, quality-by-design, and critical-to-quality principles throughout the trial life cycle. By leveraging centralized monitoring, Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs), RBQM enhances trial efficiency, improves data integrity, and safeguards patient safety while optimizing resources for high-priority risks. Regulatory bodies such as the FDA, EMA, and ICH have reinforced RBQM adoption through evolving guidelines, driving life sciences organizations to modernize their quality oversight frameworks. This report examines how RBQM platforms are transforming clinical trial execution and oversight. It evaluates leading RBQM technology providers across dimensions such as market adoption, platform functionality, technology maturity, and thought leadership. It highlights how RBQM has evolved from Risk-based Monitoring (RBM) to a holistic, technology-enabled quality management model integrating AI, predictive analytics, and real-time dashboards. These solutions are helping sponsors reduce operational burden, ensure compliance, and drive more efficient, patient-centric research. Despite increasing maturity, challenges such as data integration, organizational adoption, and standardization persist. This report provides insights into key selection considerations, trends shaping RBQM adoption, and the innovations enabling next-generation quality oversight in clinical trials. The report profiles nine leading RBQM technology providers, showcasing their capabilities and industry use cases.

eCOA solutions are transforming clinical trials by enabling accurate, real-time capture of patient, clinician, and caregiver-reported outcomes through smartphones, tablets, web portals, and provisioned devices. These platforms are redefining how clinical trials capture participant-reported data by replacing paper-based methods with secure and digital solutions. Sponsors and CROs increasingly demand flexibility, scalability, and multimodal support, driving providers to invest in innovations such as multimedia inputs, AI-enabled study setup, and seamless integration with other clinical systems. The report profiles 19 leading eCOA product providers, classifying them as Leaders, Major Contenders, and Aspirants on Everest Group’s PEAK Matrix®. It analyzes market share distribution, with a few dominant players and many niche innovators, and assesses buyer priorities – ease of use, integration, domain expertise, and flexible pricing. Key takeaways emphasize patient engagement, interoperability, and AI-driven efficiencies as essential for future growth.

Decentralized and hybrid designs add more complexity to clinical trials, generating vast data volumes from diverse sources. This complexity creates significant data management challenges. In response, sponsors are adopting unified clinical Data and Analytics (D&A) platforms to centralize and standardize clinical data for actionable insights, offering real-time monitoring, predictive analytics, and risk management. These platforms transform disparate datasets into cohesive, structured formats, helping stakeholders detect outliers, predict adverse events, and generate on-demand dashboards and reports. D&A platforms offer centralized repositories, Risk-based Quality Management (RBQM), and seamless integration with Electronic Health Records (EHRs), wearables, and medical devices. These features improve data access and interoperability, contributing to more informed decision-making and enhanced quality and risk oversight. To meet sponsor needs, clinical D&A platform providers are integrating AI and generative AI to automate repetitive tasks, generate insights, and strengthen quality and risk management. In this report, we analyze 18 clinical D&A platform providers’ capabilities and offerings. The report empowers buyers to select the right provider for their sourcing considerations and enables providers to benchmark themselves against their competition. Scope Industry: life sciences Geography: global Contents In this report, we: Examine the clinical D&A platform provider landscape Assess clinical D&A platform providers on their capabilities and market success-related dimensions Membership(s) Clinical Development Technology Sourcing and Vendor Management

Electronic Data Capture (EDC) systems are integral to clinical research, enabling clinical data collection, storage, and management. EDCs mark a significant shift from paper-based case report forms to digital and web-based trial data collection. The COVID-19 pandemic further emphasized EDC systems’ importance as the need for remote and decentralized clinical trials surged. The pandemic highlighted the need for robust, flexible, and secure data capture solutions to support treatments’ and vaccines’ rapid development and approval. These platforms have evolved to centralize data collection, improve data quality, and enable real-time clinical trial monitoring. They now integrate complex clinical data sources, such as electronic health records, laboratory data, clinical trial management systems, connected devices, and real-world data. Overall, EDC systems have significant benefits in clinical data collection, storage, and management. In this report, we assess 20 EDC product providers. The report enables buyers to choose the best-fit provider based on their sourcing considerations and empowers providers to benchmark themselves against their peers. Scope Industry: life sciences Geography: global Contents In this report, we: Examine the EDC product provider landscape Assess clinical EDC product providers on their capabilities and market success-related dimensions Membership(s) Clinical Development Technology Sourcing and Vendor Management

Life sciences enterprises are increasingly focusing on Real-world Evidence / Real-world Data (RWE/RWD) to promote patient centricity, identify the next opportunity, and demonstrate value for their investments. Enterprises are seeking next-generation solutions to address interoperability and data access challenges. This shift compels providers to innovate their offerings and introduce advanced solutions that enhance analytics and insights, enable interoperability, and enhance data security. Following suit, Oracle has launched its Analytics Intelligence for Life Sciences offering, which provides AI-enabled workflows, enhanced data interoperability, and pre-integrated datasets. In this report, we examine Oracle’s current market position, key product announcements, and industry objectives. We also review Oracle’s RWE/RWD technology and cover essential RWE/RWD issues and objectives for life sciences enterprises.  Scope Industry: life sciences Geography: global Segment: RWE/RWD platforms Contents In this report, we examine: Key enterprise RWE/RWD issues and objectives Oracle’s Analytics Intelligence for Life Sciences announcement Memberships Life Sciences Information Technology Sourcing and Vendor Management

Due to decentralized and hybrid designs, the growing clinical trial complexity generates vast data volumes from diverse sources and creates significant data management challenges. In response, sponsors are increasingly employing unified clinical data and analytics (D&A) platforms to centralize and standardize clinical data to gain actionable insights, offering real-time monitoring, predictive analytics, and risk management. These platforms transform disparate datasets into cohesive, structured formats, allowing stakeholders to detect outliers, predict adverse events, and generate on-demand dashboards and reports. D&A platforms offer centralized repositories, Risk-Based Quality Management (RBQM), and seamless integration with Electronic Health Records (EHRs), wearables, and medical devices. These features improve data access and interoperability, contributing to more informed decision-making and enhanced quality and risk oversight. Clinical D&A platform providers are incorporating cutting-edge AI and generative AI capabilities to automate repetitive tasks, generate insights, and strengthen quality and risk management to address sponsor needs. In this report, we analyze 18 clinical D&A platform providers featured on the Everest Group’s PEAK Matrix® based on their capabilities, offerings, and market impact. The report will empower buyers to choose the right provider for their sourcing considerations and enable providers to benchmark themselves against their competition. Scope Industry: life sciences Geography: global Contents In this report, we: Examine the provider landscape for clinical D&A platforms Assess clinical D&A platform providers on capabilities and market success-related dimensions Position the providers on Everest Group’s PEAK Matrix® framework as Leaders, Major Contenders, and Aspirants Compare providers’ key strengths and limitations Membership(s) Clinical Development Technology Sourcing and Vendor Management

Clinical Trial Management Systems (CTMS) are vital to modern clinical research, offering essential tools to manage and track all operational aspects of the trial process. Clinical trials’ increasing complexity, the growing data volume, and the need for enhanced collaboration have transformed CTMS platforms from basic on-premise, siloed data management systems to cloud-based, integrated systems. Initially focused on addressing manual, paper-based limitations, early CTMS lacked integration capabilities. Over time, technology advances, regulatory demands, and growing trial complexity led to the emergence of modern CTMS platforms that offer enhanced features such as integration with electronic health records, remote monitoring, and real-time actionable insights. CTMS platform providers continue to invest in AI/ML, automation, and advanced analytics to enable more efficient clinical trials. By providing real-time insights, automating routine processes, and allowing better data management, modern CTMS platforms ensure trial operations are streamlined and more effective, leading to more informed decision-making and faster trial execution. In this report, we assess 13 CTMS providers’ capabilities. The providers are mapped on the Everest Group PEAK Matrix®, a composite index of a range of distinct metrics related to a provider’s capability and market impact. Scope Industry: life sciences Geography: global Contents In this report, we assess: The CTMS product provider landscape CTMS product providers on several capabilities and market success-related dimensions Membership(s) Clinical Development Technology Sourcing and Vendor Management

The clinical development landscape is rapidly evolving, with hybrid trial approaches and the growing use of RWD/RWE. Clinical trial sponsors are increasingly challenged to manage the vast volume of data generated during multiple, simultaneously running trials. This data explosion, combined with heightened regulatory scrutiny from bodies like the US FDA, is pushing sponsors to take greater ownership in trial oversight, risk management, and patient safety. The challenge is exacerbated when clinical trials are outsourced, as sponsors lose real-time access to trial data, delaying critical decision-making and risk management. The solution lies in an end-to-end unified clinical Data and Analytics (D&A) platform, which provides a single source of truth by consolidating trial data across multiple solutions, ensuring quality and standardization and delivering real-time trial performance analytics. This report addresses the key challenges sponsors face in managing clinical data, the benefits of deploying an end-to-end unified clinical D&A platform, and implementation considerations. It is tailored to assist biopharma and MedTech enterprises, as well as contract research organizations, in streamlining their clinical data management, enhancing trial oversight, and improving decision-making. Scope Industry: life sciences Geography: global Contents In this report, we outline: The business challenges that sponsors face in managing clinical data An end-to-end unified clinical D&A platform’s benefits Key implementation considerations for clinical D&A platforms Membership(s) Clinical Development Technology Life Sciences Information Technology Sourcing and Vendor Management

Electronic Data Capture (EDC) systems are an integral part of clinical research, enabling clinical data collection, storage, and management. EDCs mark a significant shift from paper-based case report forms to digital and web-based trial data collection. The COVID-19 pandemic further emphasized EDC systems’ importance as the need for remote and decentralized clinical trials surged. The pandemic highlighted the need for robust, flexible, and secure data capture solutions to support treatments’ and vaccines’ rapid development and approval. These platforms have evolved to centralize data collection, improve data quality, and enable real-time clinical trial monitoring. They now integrate complex clinical data sources such as electronic health records, laboratory data, clinical trial management systems, connected devices, and real-world data. Overall, EDC systems offer significant benefits in clinical data collection, storage, and management. In this report, we assess 20 EDC product providers and position them on Everest Group’s PEAK Matrix®, a composite index of distinct metrics related to the providers’ capabilities and market impact. The study will enable buyers to choose the best-fit provider based on their sourcing considerations, while providers will be able to benchmark their performance against each other. Scope Industry: life sciences Geography: global Contents In this report, we: Examine the EDC product provider landscape Assess clinical EDC product providers on several capabilities and market success-related dimensions Membership(s) Clinical Development Technology Sourcing and Vendor Management

Following the Veeva-Salesforce split, the life sciences industry is undergoing significant changes in the base Customer Relationship Management (CRM) platform and associated technology tools and platforms. Additionally, enterprises seek a unified approach to engage customers across the drug development lifecycle. This approach necessitates providers to upgrade their existing offerings and introduce novel products and platforms. In response, Salesforce announced the launch of its life sciences engagement platform, Salesforce Life Sciences Cloud. This platform offers different customer engagement modules across clinical and commercial segments. In this report, we examine Salesforce’s current market position, key product announcements, and industry objectives. The report also reviews the Salesforce Life Sciences Cloud and covers essential issues and objectives around customer engagement for life sciences enterprises. Scope Industry: life sciences (biopharmaceuticals and medical devices) Geography: global Service: life sciences technology Contents In this report, we examine: Key enterprise issues and objectives for life sciences engagement platforms Salesforce’s current positioning in the market Overview of Salesforce Life Sciences Cloud announcement Everest Group’s review of Salesforce Life Sciences Cloud Membership(s) Clinical Development Technology Life Sciences Information Technology Sourcing and Vendor Management