Veeva Unveils China AI Strategy and Next-Gen Cloud Suite to Accelerate Global Expansion of Chinese Innovative Therapeutics

Over the past decade, the number of new clinical trials initiated in China has shown a year-on-year increase. By 2024, China had registered more than 7,100 clinical trials on the World Health Organization’s International Clinical Trials Registry Platform (ICTRP), surpassing the United States’ 6,000-plus trials and ranking first globally for the first time.

As the number of clinical trials surges, competition and risks escalate concurrently. For sponsors, improving efficiency across all processes while ensuring clinical trial quality has become an urgent priority.

As a witness to and participant in the changing times, Veeva Systems (NYSE: VEEV), the global leader in life sciences cloud solutions, has been collaborating with domestic pharmaceutical companies to advance clinical trials and accelerate globalization.

In September 2025, at the “Smart Global Connectivity, Efficiency Innovation – 2025 Veeva China R&D and Quality Summit” held in Shanghai, Veeva significantly upgraded and launched its next-generation cloud products, aiming to collaborate with numerous renowned pharmaceutical companies to gain insights into the evolving global pharmaceutical landscape and secure competitive advantages at critical junctures.

The new products launched in this upgrade include the Safety pharmacovigilance application on the Veeva R&D Cloud platform and a brand-new Quality Cloud solution.

In the future, Veeva R&D and Quality Cloud will center on “Single Platform + Comprehensive Compliance + Global Coordination + AI Empowerment” to build a full-chain digital foundation covering R&D, manufacturing, and commercialization. It directly addresses the pain points of Chinese innovative pharmaceutical companies—namely, difficulties in multi-regional compliance, slow cross-team collaboration, fragmented data standards, and soaring costs—achieving “increased efficiency and effectiveness, and reduced costs” (two increases, one decrease). This will help innovative pharmaceutical companies accelerate their transition toward globalized and modernized operational management models, simplify and standardize business processes, improve operational efficiency, and expedite new drug launches.

On-site at the 2025 Veeva China R&D and Quality Summit

In light of the new dynamics in China’s clinical trials, Chris Shim, General Manager of Veeva’s R&D and Quality Business for Asia Pacific, stated: “The globalization of China’s innovative drugs is not an ‘optional question’ but a ‘mandatory one.’ Leveraging our 18 years of deep expertise in the life sciences industry and our extensive ecosystem footprint, we will help Chinese innovative pharmaceutical companies achieve efficient, high-quality, and compliant management of drugs from R&D to production through digitalization and intelligence. This will accelerate their global expansion, ensuring that every investment in innovation by Chinese pharmaceutical companies yields maximum returns in the global market, while enabling all patients to access higher-quality and more affordable medicines.”

Beyond China, the deepening globalization of drug development and the surge in clinical trial volumes are compelling global regulatory systems to impose new requirements for compliance and quality management across the entire R&D lifecycle. This entails that clinical operations, quality management, and regulatory submissions must undergo more stringent regulatory oversight and review.

For the industry, these new requirements can ensure project quality amid the growth of clinical trials, thereby safeguarding the overall development of the pharmaceutical sector. However, meeting these requirements will impose additional compliance costs on sponsors, potentially weakening pharmaceutical companies with lower levels of digital and intelligent transformation.

Taking pharmacovigilance as an example, Chinese pharmaceutical companies, in their expansion into overseas markets, must simultaneously comply with divergent regulatory requirements across multiple jurisdictions, including those of the NMPA, FDA, and EMA. Manual processing not only struggles to meet the timeliness demands of multi-regional compliance but is also prone to reporting failures due to discrepancies in format adaptation. Consequently, there is an increasingly urgent industry demand for digital solutions capable of navigating complex multinational regulatory frameworks and enabling standardized, one-click submissions to multiple regulatory authorities.

To address the new challenges faced by enterprises, Veeva’s strategy is to build end-to-end solutions and make timely adjustments in accordance with regulatory requirements. For instance, Veeva China R&D and Quality Cloud is an upgraded solution built on the Veeva Vault platform, providing domestic innovative pharmaceutical companies with an integrated system solution that covers the entire lifecycle of new drugs.

These solutions cover core areas including clinical data, clinical operations, pharmacovigilance, regulatory submissions, and quality management, enabling Chinese pharmaceutical companies to resolve the majority of process-related challenges in R&D in a single step.

Breaking down Veeva’s R&D and Quality Cloud innovations for this year, we can focus on three areas: pharmacovigilance, quality management, and the integrated clinical platform.

As the global expansion of China’s innovative pharmaceutical industry accelerates and the overseas regulatory landscape becomes increasingly complex, Chinese innovators must not only navigate the stringent oversight of the National Medical Products Administration (NMPA) domestically but also meet the multifaceted compliance requirements of major regulatory authorities abroad, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). In this context, the limitations of traditional decentralized management models have become increasingly pronounced, with issues such as slow case processing, low levels of automation, non-compliant report submissions, and difficulties in coordinating data across multiple regions growing more prominent.

To address the aforementioned issues, Veeva has launched its pharmacovigilance application, Veeva Safety, for the Chinese market for the first time. As a key component of Veeva Vault R&D Cloud, it seamlessly integrates with other Veeva products and provides automatic updates three times a year.

Veeva Safety pharmacovigilance application meets the standards of major regulatory authorities in China and globally (NMPA, FDA, EMA, PMDA, etc.), providing end-to-end coverage from safety data intake and case processing to medical review and regulatory report submission. It supports fully automated ingestion and entry of adverse events from multiple sources and complies with global E2B R2/R3 submission standards. Through visual operational dashboards, enterprises can track compliance progress in real time, truly achieving “a single system that satisfies multi-regional global regulatory requirements across China, the United States, Europe, and Japan.”

In previous practice, the Veeva Safety pharmacovigilance application has been validated in the global market: 8 of the top 20 biopharmaceutical companies worldwide have adopted the Veeva Safety Suite, and its core components, Veeva Safety and Veeva SafetyDocs, serve over 80 global clients.

For Chinese innovative pharmaceutical companies today, the value of Veeva Safety’s pharmacovigilance application lies in its tangible delivery of “cost reduction and efficiency enhancement.” According to real-world application data, this solution helps enterprises cut system operation and maintenance costs by 50%, accelerate business process changes by 80%, and speed up application upgrades by 90%. While simplifying compliance operations, it reduces labor costs and boosts corporate productivity, providing a powerful engine for compliant management and efficient operations throughout the entire drug lifecycle.

For a long time, Chinese pharmaceutical companies have often established fragmented “siloed quality systems” to meet the compliance requirements of different regions and functions—R&D has its own document management system, production uses independent quality management tools, and laboratories rely on separate data platforms.

Due to the lack of unified data standards, this model often suffers from data silos and disjointed processes. This not only causes efficiency losses such as “repeated entry of the same deviation across multiple systems” and “difficulty in synchronizing supplier quality data to R&D,” but also makes it difficult for pharmaceutical companies to identify potential risks in advance, trapping them in a passive compliance dilemma of “post-event remediation.” This severely restricts the improvement of operational efficiency and the ability to manage quality risks in the advancement of global business.

Against this backdrop, the new generation of Veeva Quality Cloud has emerged, centered on “unified, intelligent, and interconnected” principles to precisely address this pain point. It integrates core application systems—including QualityDocs for document management, QMS for quality management, and LIMS for laboratory management—into a single platform, building an end-to-end quality ecosystem that spans “R&D, manufacturing, and supply chain.” This advancement leads the industry into a new era of truly proactive, efficient, and enterprise-wide quality management, transforming quality management from a toolkit for ensuring compliance into a strategic platform driving business excellence.

Extracting its value hinges on achieving the "three integrations":

1. Data integration: Centralized management of master data—including suppliers, personnel, and products—to mitigate compliance risks arising from data inconsistencies across multiple systems;

II. Streamline processes by leveraging automated workflows (e.g., automatically triggering company-wide training tasks upon SOP updates, and enabling one-click linkage of laboratory anomalous data to deviation handling processes), thereby shifting quality control from “manual-driven” to “system-driven.”

3. Business Integration: Supports seamless integration with Veeva R&D Cloud’s clinical data and regulatory submission system platforms, ensuring compliance and consistency in global quality management. For instance, quality risks identified during the clinical phase can be directly synchronized to the manufacturing side, enabling proactive optimization of process parameters and achieving collaborative synergy among R&D, production, and quality assurance.

This “proactive interconnectivity” model transforms quality management from a mere compliance tool into a strategic pillar driving business enhancement. Pharmaceutical companies can leverage end-to-end data visualization to proactively identify risks—for instance, rapidly tracing quality fluctuations in a specific batch of raw materials back to the supplier and adjusting procurement strategies accordingly. Furthermore, by adhering to unified standards that meet global regulatory requirements, they establish a robust quality foundation for their global expansion.

Revisiting the Upgraded Veeva Unified Clinical Platform. As a key component of Veeva R&D Cloud, it builds all core applications—including Clinical Trial Management System (CTMS), data management (EDC, CDB, eCOA), and Trial Master File (eTMF) management—on a unified Vault platform. This ensures data integrity, real-time accessibility, and traceability, leveraging end-to-end visibility and data integration capabilities to help Chinese innovative pharmaceutical companies demonstrate their trial quality and management standards to regulatory authorities such as the FDA and EMA, thereby meeting evolving stringent regulatory requirements.

While adhering to the highest international standards such as ICH-GCP, it also offers flexible configuration to accommodate subtle differences across various countries and regions, helping Chinese innovative pharmaceutical companies establish a high-standard global clinical operations system from the very beginning of their global expansion.

Compared with other platforms, the Veeva Unified Clinical Platform naturally connects sponsors, CROs, and global research centers. Chinese innovative pharmaceutical companies can conduct real-time, transparent oversight, collaboration, and unified management of their global CRO partners and clinical trial projects, ensuring that global trials are executed to consistent high standards. This breaks down geographical and organizational barriers, significantly enhancing efficiency and engagement.

Built on the integrated Vault platform, the Veeva Unified Clinical Platform and the Veeva RIM Regulatory Submission Platform work seamlessly together. By leveraging a single data stream within a common data model, they enable end-to-end integration of clinical trials, clinical data, and regulatory activities. This ensures high compliance, enhances R&D speed and efficiency, significantly accelerates new drug approval, and brings innovative therapies to market sooner.

Regarding Veeva’s future strategic layout in the Chinese market, Ma Xiamiao, Vice President of R&D and Quality Business and Head of China Operations, stated in her speech: “China is one of Veeva’s key global strategic markets. Our mission is clear: leveraging our experience serving over 1,500 life sciences companies worldwide, we deeply integrate with the localized needs of Chinese pharmaceutical enterprises. We not only meet domestic regulatory requirements but also align with global standards set by major overseas regulatory authorities in the United States, Europe, and Japan. Through our globally unified R&D and Quality Cloud platforms and solutions, we enable Chinese innovative drugs to achieve ‘build once, use globally’ across R&D, quality, and compliance. This constitutes our core competitive advantage differentiating us from other solutions.”

In line with this, Veeva unveiled its latest AI strategy for the R&D and Quality Cloud sectors in China at this year’s summit. The company plans to integrate AI into the unified Vault platform and core applications of Veeva R&D and Quality Cloud, enabling innovative pharmaceutical companies in China of all sizes to rapidly, easily, securely, and compliantly implement AI solutions, thereby effectively empowering business growth.

Currently, Veeva has built an Agentic AI-integrated, unified Vault platform and developed various AI Agents based on it. In core applications such as pharmacovigilance, clinical operations, regulatory submissions, quality management, and clinical data, AI will help pharmaceutical companies achieve automation and intelligence across the entire process from R&D to production, thereby enhancing employee productivity.

 Veeva AI Mechanism of Action

In Veeva’s vision, these capabilities will be continuously integrated into its platform and core applications. First, AI will be closely aligned with pharmaceutical business operations to enable rapid deployment. Second, convenient, secure, and high-speed API access and data interoperability will be provided to supply ample data “fuel” for pharmaceutical companies’ AI applications. Finally, Veeva will collaborate with top-tier partners in the global AI ecosystem to jointly promote the adoption of AI best practices and drive innovative development.

Overall, Veeva AI aims to build a complete closed-loop system characterized by “intelligent core systems, interconnected data ecosystems, and co-built industry ecosystems,” ensuring that AI can be rapidly, securely, and compliantly implemented within pharmaceutical companies to empower business growth.

At the summit, multiple speakers noted that the complexities of global operations are beyond imagination, and choosing a commercial path involves intricate strategic maneuvering. It is essential to make digitalization a core corporate competency from the outset by prioritizing digital-native strategies and digital governance before unlocking the value of data. As intelligent tools become widely adopted and implemented in the pharmaceutical industry, new technologies will undoubtedly elevate industry-wide mindsets, operational efficiency, and outcomes, driving sustainable, intelligence-led growth for life sciences enterprises.