eClinical Solutions LLC, a global provider of digital clinical software and services, today announced a strategic partnership with ZS, a leading global management consulting and technology firm, to deliver an enhanced risk-based quality management (RBQM) offering tailored for the life sciences industry. This collaboration is designed to unify data, analytics, and expertise, helping sponsors manage risks, ensure quality, and improve the efficiency of clinical trials across their portfolios.
The partnership integrates eClinical’s elluminate Clinical Data Cloud®—an AI-powered clinical data infrastructure and analytics platform—with ZS’s extensive experience in RBQM strategy, consulting, and custom-built solutions. Together, the two companies aim to provide sponsors with a comprehensive, end-to-end solution that embeds risk management directly into clinical trial operations, driving measurable improvements in trial quality, compliance, and efficiency.
“Our vision is to transform RBQM the same 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 not only to comply with RBQM guidance but also to proactively elevate the quality and efficiency of their entire clinical trial portfolio, all within a single, integrated platform.”
RBQM Embedded in a Single Platform, Reducing Complexity for Clinical Teams
Historically, RBQM has often been siloed across systems, requiring clinical teams to navigate multiple tools and workflows. With the integration of ZS expertise and elluminate technology, sponsors can now manage risk in a more holistic and seamless way. The elluminate RBQM solution empowers clinical teams to:
- Proactively identify and manage study, process, and vendor risk at both the individual study and portfolio levels, enabling a proportionate and strategic approach to oversight.
- Improve true positive detection by tailoring statistical monitoring to specific organizational and trial needs, moving beyond generic “black-box” monitoring to actionable, insight-driven outcomes.
- Streamline collaboration across process, vendor, program, and asset oversight teams using role-based workflows and real-time dashboards.
- Enhance compliance and regulatory readiness with capabilities aligned to ICH E6(R3), ICH E8(R1), MHRA, and other evolving global and regional guidance, ensuring that quality and risk management processes are inspection-ready.
By embedding RBQM directly into the clinical data infrastructure, eClinical Solutions and ZS remove the complexity and fragmentation that often challenge trial teams, providing a single source of truth and integrated platform for risk assessment and mitigation.
Combining ZS Expertise with eClinical Technology to Drive Clinical Innovation
ZS brings extensive consulting, technology, AI, and analytics expertise to the partnership. With years of experience supporting R&D organizations, ZS helps sponsors unify risk assessment, monitoring, and oversight across clinical portfolios. The firm already works with 10 of the top global pharmaceutical sponsors and provides end-to-end RBQM subject-matter expertise, strategy, and guidance.
By combining ZS’s expertise with eClinical’s AI-powered technology, sponsors gain access to:
- An industry-leading approach to risk assessment, streamlining and enhancing processes critical to trial quality and regulatory compliance.
- A single source of truth for cross-functional risk-based data review, enabling integrated decision-making across studies, processes, and vendors.
- Portfolio-level insights to ensure a proportionate approach to managing risks at all levels of the clinical trial lifecycle.
- Actionable analytics with embedded workflows for easy identification of root causes, focused corrective actions, and efficient issue resolution.
- Documented, inspection-ready evidence of risk communication and mitigation activities, supporting regulatory compliance and audit preparedness.
- AI-enabled intelligence to enhance quality and risk management across the clinical development lifecycle.
- Strategic guidance from industry subject-matter experts, ensuring that adoption is aligned with best practices and emerging RBQM standards.
- Implementation support for rapid time-to-value and sustainable adoption across the organization.
Setting a New Standard for RBQM Across the Clinical Portfolio
The ICH E6(R3) guideline emphasizes the importance of identifying, evaluating, and mitigating Good Clinical Practice (GCP) risks across studies, processes, vendors, and the overall clinical trial system. This partnership enables sponsors to implement a fully integrated RBQM approach that addresses these requirements while simplifying and accelerating risk-based data review, quality oversight, and analytics.
Through this collaboration, sponsors gain access not only to advanced technology but also to guidance on deployment and change management, ensuring that RBQM adoption is both efficient and sustainable. By embedding risk management at scale, sponsors can improve decision-making, reduce trial complexity, and optimize resource allocation across programs.
“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 are helping sponsors streamline fragmented approaches and embed risk management across the development portfolio, processes, and vendors.”
Driving Quality and Efficiency Through Innovation
The eClinical-ZS partnership reflects a broader industry trend toward leveraging AI, analytics, and integrated platforms to enhance clinical trial quality. By combining technological innovation with strategic consulting expertise, sponsors are now able to:
- Identify risks earlier and implement mitigation strategies proactively.
- Align cross-functional teams on consistent workflows and priorities.
- Leverage portfolio-level data to inform resource allocation and decision-making.
- Improve regulatory compliance and reduce the burden of audits and inspections.
This unified approach to RBQM represents a significant shift from traditional, fragmented risk management practices. By integrating strategy, analytics, and technology, sponsors can now gain a comprehensive, real-time view of risk across their entire clinical portfolio, enabling more informed decisions and ultimately driving better outcomes for patients.
A Vision for the Future of RBQM
Through this partnership, eClinical Solutions and ZS aim to set a new industry standard for RBQM, delivering an intelligent, AI-enabled platform combined with expert consulting to support the life sciences industry in achieving higher efficiency, enhanced quality, and regulatory compliance.
“Together, we are transforming the way risk is managed across clinical trials,” said Indupuri. “By embedding RBQM into a single platform and combining it with expert guidance, we’re helping sponsors move from reactive compliance to proactive quality management—ultimately improving the speed, efficiency, and success of clinical trials.”
With this collaboration, life sciences organizations now have access to a robust, unified solution for risk-based quality management—one that integrates AI, analytics, and expert insight into a single platform and supports proactive, data-driven decision-making across all clinical trials.
