Veeva Bolsters 'Development Cloud' to Empower Chinese Pharma Companies Going Global

In this era of globalization, the vision of innovative pharmaceutical companies is no longer confined to their domestic markets. “Going global,” a term brimming with adventurous spirit and endless possibilities, is becoming a critical step in the strategic planning of an increasing number of enterprises.

However, while expanding overseas may seem straightforward, it is fraught with risks. In confronting well-established multinational pharmaceutical giants, Chinese innovative drug companies urgently need to strengthen their R&D capabilities, elevating both the “efficiency” and “quality” of their research and development to international standards, thereby gaining recognition for their R&D prowess in overseas markets.

On June 27, 2024, Veeva Systems (NYSE: VEEV), a cloud solutions provider for the life sciences industry, held the “2024 Veeva China R&D and Quality Summit” in Shanghai under the theme “Reducing Costs, Enhancing Quality, and Boosting Global Competitiveness,” aiming to provide answers to the aforementioned challenges.

During the event, dozens of industry leaders from prominent pharmaceutical companies—including Zai Lab, Hutchmed, GeneScience Pharmaceuticals, Junshi Biosciences, Henlius, Bayer, Takeda, and BeiGene—attended and engaged in in-depth discussions on key industry topics such as global expansion strategies for innovative drugs, modern quality management, digital clinical operations, EDC and clinical data management, and reforms in regulatory submission processes. These discussions aimed to address the various challenges faced by innovative pharmaceutical companies in their digital transformation and global expansion efforts.

The so-called digital transformation of the pharmaceutical industry refers to the comprehensive reshaping and upgrading of business, organization, processes, products, services, and other aspects of the pharmaceutical industry by leveraging information technology and digital tools, with the aim of achieving business model innovation, improved efficiency, optimized customer experience, and accelerated growth.

At the conference, Cai Kanghong, Vice President of IT at Zai Lab, simplified this concept and shifted its focus. In his view, digital transformation involves transitioning from scattered technological experiments to the formulation and execution of a systematic strategy.

“Like many leading innovative pharmaceutical companies, Zai Lab engaged with the digital wave early on, attempting to achieve rapid digital transformation by quickly deploying tools. However, in practice, the performance of these transformation initiatives was less than ideal. We later realized that digital transformation in the pharmaceutical industry cannot merely involve the haphazard integration of digital tools. Instead, it is essential to establish a core strategy amidst fragmented technologies at the outset of the transformation, and to continuously reflect and improve throughout the process, in order to achieve efficient digital transformation,” stated Cai Kanghong.

“When confronting innovative tools, we should first ask ‘why’ before asking ‘how,’ to assess whether organizational transformation is necessary and feasible. Furthermore, while digital tools are undoubtedly important during the transformation process, the most critical factor is identifying an appropriate leadership approach to drive the efficient completion of the transformation.”

Fu Zhifan, Senior Vice President of Quality Assurance at Hutchmed, offered his insights on the increasingly popular topic of global expansion. He believes that Chinese innovative pharmaceutical companies, regardless of their target overseas markets, should not focus solely on R&D and sales in those specific destinations. Instead, they should adopt a global strategy aimed at curing patients worldwide.

“When a company plans to develop a new drug, it must clearly define the drug’s market positioning at the time of its approval ten years down the line. If the drug cannot break into the global top three upon launch, there is no point in pursuing it; no matter how effective the drug may be, its market competitiveness will struggle to rival that of the leading contenders.”

Furthermore, companies must clarify their clinical development plans. It is well known that the success of innovative drugs hinges on clinical data; the higher the quality of the data, the greater the likelihood of entering an expedited review pathway, thereby enhancing the company’s risk tolerance. If a drug fails to qualify for such expedited pathways, the costs associated with regulatory approval can be substantial, forcing companies to carefully consider whether to continue their clinical development efforts.

In addition to the valuable insights shared by numerous leading innovative pharmaceutical companies, conference organizer Veeva also unveiled its new products from the Veeva Development Cloud tailored for the Chinese market. These include Vault Study Training (clinical trial training system), Veeva Site Connect (site connectivity system), Veeva RTSM (randomization and trial supply management system), Veeva ePRO, Veeva eClinRO, Vault LIMS (laboratory information management system), and Vault Validation Management (validation management system). These solutions are designed to help innovative pharmaceutical companies accelerate their digital transformation and enhance their global competitiveness.

Veeva R&D Cloud is a digital cloud platform built on the modern Vault Platform (Veeva Vault Platform) that spans the entire lifecycle of drug development, manufacturing, and commercialization. It currently serves over 1,000 life sciences customers worldwide, including large multinational pharmaceutical companies, emerging biotechnology firms, CROs, and medical device companies. Veeva R&D Cloud provides pharmaceutical clients with comprehensive digital solutions covering the full lifecycle from new drug development to market launch, facilitating their digital transformation and upgrading.

According to Lu Wenjie, Head of Veeva China’s R&D Cloud business, the Veeva R&D Cloud currently launched for the Chinese market encompasses more than 20 applications and systems, primarily covering five key domains: Clinical Data Management (Veeva Vault CDMS), Clinical Operations (Veeva Vault Clinical Operations), Quality Management to ensure compliance throughout R&D and commercialization (Veeva Vault Quality), Regulatory Information Management as a critical component of new drug launches (Veeva Vault RIM), and Pharmacovigilance regulation closely tied to patient safety across both clinical development and post-marketing stages (Veeva Vault Safety).

Through integration via Vault Connection, seamless data and document transfer can be achieved across different Vaults. As a result, data and content can flow freely and be readily accessed across key pharmaceutical business processes and functions, including clinical operations, quality management, regulatory affairs, and pharmacovigilance. By breaking down silos between different business departments, enhancing visibility, automating tasks, and simplifying cross-functional workflows, this approach ensures single-source truth and consistency for all data and content within a unified platform, thereby safeguarding operational compliance and driving high operational efficiency.

In the field of AI applications, products such as Veeva TMF Bot and RIM Bot offer AI-powered functionalities. With the rapid development of generative artificial intelligence and the growing demand for it within the life sciences industry, Veeva has launched the new Veeva AI Partner Program. Through Vault Direct Data API and the AI Partner Program, customers and partners can more easily develop and build AI applications and solutions that seamlessly integrate with Vault applications. This supports life sciences enterprise customers in rapidly leveraging AI to drive growth.

Veeva R&D Cloud: Covering 20+ application systems, providing one-stop coverage for the entire pharmaceutical enterprise workflow

Overall, the practical value of Veeva R&D Cloud can be summarized into the following four points:

First, it can accelerate the global R&D of innovative drugs, reducing costs and increasing efficiency. The complexity of the R&D process, long development cycles, and high investment costs are common pain points in new drug development. Veeva R&D Cloud is a global, integrated cloud solution built by Veeva on its unified enterprise-grade Vault platform to meet the needs of the global life sciences industry. Compliant with international standards and global business processes, it ensures compliance and high efficiency across the entire R&D lifecycle—including clinical operations, quality management, regulatory submissions, and drug safety—on a global scale.

Second, it can help pharmaceutical companies efficiently conduct more complex global clinical trials and cope with stricter compliance regulations. Clinical trials are a critical component of innovative drug development, requiring the recruitment of a large number of volunteers and long-term monitoring and evaluation of participants. In terms of clinical data management, differences in data standards, data protection, and privacy regulations across countries and regions may exist, posing challenges for innovative pharmaceutical companies in data standardization and compliance. Additionally, clinical operations must comply with regulatory requirements in different countries and regions. Furthermore, as conducting international multi-center clinical trials (MRCT) becomes a trend for innovative pharmaceutical companies expanding globally, issues such as the accuracy and completeness of data collection across multiple research centers, countries, and regions, as well as effective collaboration among multi-centers, are being tested.

Empowered by Veeva Clinical, the clinical digitalization solution provided by Veeva R&D Cloud, innovative pharmaceutical companies expanding globally can manage clinical trials more rapidly and efficiently on a compliant foundation that adheres to global regulatory standards. This ensures the standardization, accuracy, and integrity of data in global trials, while facilitating the efficient and smooth conduct of global multi-center clinical studies through enhanced collaboration among subjects, research centers, and new drug developers.

Third, it can help accelerate overseas registration and market approval. By obtaining overseas registration and approval, innovative drug companies can access broader international markets. However, differences in pharmaceutical regulatory systems across countries and regions pose challenges to the overseas registration and approval of Chinese innovative drugs.

Veeva R&D Cloud offers a global digital regulatory submission solution based on Veeva Vault RIM, helping innovative pharmaceutical companies centrally manage regulatory information worldwide. By leveraging automated workflows, task management, and submission document status tracking, it accelerates the regulatory submission process, reducing time and costs. The solution supports multi-country regulatory requirements and features robust security and compliance capabilities, enabling innovative pharmaceutical companies to ensure compliance and traceability throughout the submission process, thereby better supporting their overseas regulatory submissions.

Fourth, achieve compliant, unified, and efficient global quality management. The stability and reliability of drug quality are critical to patient safety. Due to variations in drug quality control standards across different countries and regions, innovative pharmaceutical companies face numerous challenges in ensuring that their manufacturing processes and quality control standards meet the requirements of target markets.

Through Veeva Vault Quality’s integrated digital quality solution, innovative pharmaceutical companies can modernize global quality management by consolidating applications for quality processes, content, laboratory, and training management onto a single cloud platform. This enables coordinated and effective quality management across different countries and regions, achieving compliant, unified, and efficient global quality management.

Lu Wenjie stated at the conference: “As of June 2024, Veeva R&D Cloud has been adopted by more than 1,000 life sciences companies worldwide to revolutionize pharmaceutical R&D processes and accelerate digital transformation, enabling a significant number of pipelines to reach market launch.”

In the future, Veeva will continue to drive the adoption of its R&D Cloud in China, providing advanced technologies and digital systems with global competitiveness. This will help Chinese innovative pharmaceutical companies streamline R&D processes, improve R&D efficiency and quality, achieve cost reduction and quality enhancement, boost their competitiveness in the international market, and ultimately benefit more patients.