Collaboration unites elluminate platform technology and ZS RBQM expertise to offer a fully integrated, data-driven approach to risk and quality management

eClinical Solutions LLC, a global provider of digital clinical software and services, today announced a strategic partnership with ZS, a global management consulting and technology firm, to deliver an enhanced risk-based quality management (RBQM) offering for the life sciences industry.

The collaboration pairs eClinical’s elluminate Clinical Data Cloud®—the AI-powered clinical data infrastructure and analytics platform—with ZS’s proven RBQM consulting and custom-built RBQM solution expertise. Together, eClinical Solutions and ZS will provide sponsors a unified experience designed to transform how organizations manage risks, ensure quality, and drive trial efficiency.

“Our vision is to transform RBQM the way elluminate has already transformed data infrastructure and analytics within our industry,” said Raj Indupuri, CEO and co-founder of eClinical Solutions. “By joining forces with ZS, we are enabling our clients to not only comply with RBQM guidance, but also to proactively elevate the quality and efficiency of their entire clinical trial portfolio within a single platform.”

RBQM Embedded in a Single Platform, Reducing Complexity for Clinical Teams

Through seamless integration with clinical data review and analytics, elluminate RBQM empowers sponsors to:

• Proactively identify and manage protocols, process, and vendor risk at both the study and portfolio levels

• Improve true positive detection by tailoring statistical monitoring to organizational needs, moving beyond “black-box” monitoring to deliver actionable insights

• Streamline collaboration across process, vendor, program, and asset oversight teams with role-based workflows and real-time dashboards

• Enhance compliance and readiness with capabilities aligned to ICH E6(R3), ICH E8(R1), MHRA, and other evolving global and regional regulatory guidance

Combining ZS Expertise with eClinical Technology to Drive Clinical Innovation

ZS leverages its consulting, tech, AI, and analytics services to help R&D organizations unify risk assessment, monitoring, and oversight. The firm offers end-to-end RBQM subject-matter expertise and strategy, and already works with 10 of the top global pharma sponsors. Aligning ZS’s offerings with eClinical’s technology leadership delivers an intelligent RBQM solution and consultancy that streamlines adoption and provides:

• An industry-leading approach to streamline and enhance the required risk assessment process

• A single source of truth for cross-functional risk-based data review needs

• Portfolio-level insights to ensure oversight and a proportionate approach to managing study, process, and vendor risks

• Actionable analytics with embedded workflows for easy identification of root causes and focused actions

• Documented, inspection-ready evidence of risk communication and management

• AI-enabled intelligence to elevate quality and risk management approaches

• Strategic industry subject-matter expert guidance

• Implementation support for rapid time-to-value and sustainable adoption

Setting a New Standard for RBQM to Support the Clinical Portfolio

The ICH E6(R3) guideline recommends identifying, evaluating, and mitigating good clinical practice (GCP) risks across studies, processes, vendors, and the clinical trial system. With this partnership, sponsors gain access to an RBQM system that integrates and simplifies these parameters while streamlining advanced risk-based data review, quality oversight, and analytics in a single AI-powered platform. Sponsors will also have access to guidance to support effective deployment and change management.

“ZS has long led the way in advanced RBQM strategy and custom solutions. Partnering with eClinical Solutions offers us the opportunity to bring to life our shared vision of an integrated risk assessment and data review platform,” said Jonathan Rowe, Ph.D., principal and head of R&D quality, operations and risk management at ZS. “Together, we’re helping sponsors streamline fragmented approaches and embed risk management at scale, across the development portfolio, processes, and vendors.”

About eClinical Solutions LLC

eClinical Solutions’ industry-leading data & analytics platform, elluminate^®, and biometrics services experts help biopharma researchers at large, mid-size, and emerging life sciences organizations manage trial complexity in less time and with fewer resources. Clients get accurate and timely data insights for better decision-making – enabling them to reduce cycle times, improve productivity, easily scale, and develop tomorrow’s breakthroughs with today’s resources. eClinical is a privately-held, purpose-driven company with a global workforce and winner of two 2025 Top Workplaces Culture Excellence Awards, the 2024 Top Workplaces USA Award, and Great Place To Work^® India Certification™. Learn more at www.eclinicalsol.com and follow eClinical Solutions on LinkedIn.

About ZS

ZS is a management consulting and technology firm that partners with companies to improve life and how we live it. We transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Founded in 1983, ZS has more than 13,000 employees in over 35 offices worldwide. To learn more, visit www.zs.com or follow us on LinkedIn.

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