Accelerating the Digital-Intelligent Transformation of Clinical Research in China Amid AI-Driven Biopharmaceutical Engineering Evolution and Paradigm Shift

In the era defined by AI, the digital and intelligent transformation of clinical research has become an irreversible trend.

On one hand, competition in the global biopharmaceutical industry is intensifying. The cost of new drug development is rising, R&D cycles are continuously lengthening, and requirements for clinical research are becoming increasingly stringent. Challenges in clinical trial design and data management are growing more severe. As a key raw material for clinical research, real-world data (RWD) further increases the complexity of study design and data application. On the other hand, the rapid advancement of AI technology provides robust technical support for the digital and intelligent transformation of clinical research. AI not only enhances the efficiency of data processing and analysis but also leverages machine learning and deep learning to predict clinical trial outcomes, optimize trial designs, and improve success rates. Furthermore, AI plays a significant role in various aspects of clinical research, including protocol design, selection of inclusion/exclusion criteria, patient recruitment and screening, identification and analysis of risk factors, digital twins, synthetic control arms (SCA), virtual clinical trials, and data management and analysis, thereby further advancing the automation and intelligence of clinical trials.Furthermore, empowered by high-quality medical data and artificial intelligence technologies, a more profound paradigm shift in clinical research is being driven at the fundamental logical level. Biopharmaceuticals are no longer merely an exploratory scientific endeavor; in the future, they will most likely evolve toward a computable, engineering-oriented operational paradigm.

However, the digital and intelligent transformation of clinical research also faces challenges, particularly in terms of data availability and quality. Leveraging AI technologies to assist human efforts in data quality management and process standardization, thereby enhancing quality standards, remains a primary challenge for Chinese medical institutions and clinical research innovators as they engage in global competition.

On September 12, 2024, under the guidance of CCHRPP, the Shanghai Biomedical Industry Promotion Center, and the Internet Medical Health Industry Alliance,The “Journeying Far from Near: Enhancing Quality with New Productive Forces, Summit Forum on Innovative Transformation of Digital and Intelligent Clinical Research,” hosted by PRIME Life Sciences and co-organized by IQVIA and Quintiles Translational Solutions, was successfully held in Shanghai.The conference invited a wide range of stakeholders in clinical research, including hospital GCP offices, multinational pharmaceutical companies (MNCs)/biotech firms, clinical CROs, digital and intelligent technology innovators, and investment institutions. Through multiple dimensions such as trend insights, global perspectives, ecosystem collaboration, and multi-party synergy, the event aimed to deeply explore how digitalization and intelligence are leading new transformations in clinical research, and to jointly envision emerging trends for the future development of this field.

Conference Venue

As new methods, technologies, and tools continue to emerge, R&D efficiency has become a core competitive advantage for countries and regions worldwide, driving market growth in the global pharmaceutical industry through innovation. In this context, the digital and intelligent transformation of clinical research will serve as a key driver for global pharmaceutical companies to promote R&D innovation and efficiency.

At the conference venue,Dr. Mi Zihou, President of IQVIA Asia Pacific, explored global trends in the pharmaceutical industry from four perspectives: market dynamics, financing, R&D efficiency, and business transactions.In terms of the market, approximately 350 new drugs are expected to be launched globally over the next five years, with the market size projected to reach $2.3 trillion and an annual growth rate of 5% to 8%, demonstrating the robust vitality and significant market potential of the global pharmaceutical industry.

Dr. Zihou Mi, President of IQVIA Asia Pacific

In terms of financing, although fundraising activities in the pharmaceutical industry declined in 2022, they rebounded in 2023 and are projected to surpass the previous year’s levels in 2024. Financing activities in China’s medical device and pharmaceutical sectors have already exceeded pre-pandemic levels, underscoring the country’s growing importance in global pharmaceutical research and development.

In terms of R&D efficiency, although the success rate of pharmaceutical research and development has improved, the time from patent to product launch has lengthened, and clinical trials have become more complex. The increased enrollment time for clinical trials and heightened regulatory approval requirements are the major challenges currently facing the industry.

In terms of business transactions, Dr. Mi Zihou emphasized the critical role of small enterprises in global pharmaceutical R&D, particularly highlighting the significant growth achieved by Chinese companies in this sector. He predicted that a substantial number of innovative drugs will come to market over the next five years, ushering in new growth drivers in the fields of oncology and immunotherapy.

Facing a new round of global competition and the race for R&D efficiency, Dr. Mi Zihou believes that digital technologies and artificial intelligence will effectively enhance the efficiency of pharmaceutical research and development. “The core vision of the pharmaceutical industry is to deliver the right drug to the right patient at the right time. Although the industry faces many challenges and unmet clinical needs, technological advancements have provided us with more solutions, while government efforts to improve the accessibility of innovative drugs have further accelerated market development,” stated Dr. Mi Zihou.

Dr. Gu Chengming, Head of the Medical Affairs Department, Sanofi Greater ChinaIt also emphasized the potential of AI in scientific research, particularly in study design, selection of inclusion and exclusion criteria, identification of risk factors, digital twins and trial outcome prediction, as well as data management and analytical applications for synthetic control arms (SCA). He stated that, empowered by high-quality data and intelligent technologies, clinical R&D in biopharmaceuticals will no longer be merely an exploration of scientific questions but will evolve into an engineering discipline, with a focus on cost reduction and efficiency enhancement. In the face of the two major challenges of high costs and long cycles in current clinical research, digital technologies can effectively improve efficiency, reduce costs, and enhance quality. “AI4S: AI For Science” will usher in a new era for clinical research.

Gu Chengming, Head of the Medical Department, Sanofi Greater China

Dr. Gu Chengming believes that with the increasing availability of real-world evidence (RWE), we have the opportunity to generate new hypotheses and find synergies between RWE and randomized controlled trials (RCTs). He illustrated how insights derived from observational studies can be validated in RCTs, thereby optimizing study design. Dr. Gu also shared how AI can be leveraged to optimize inclusion criteria and predictive models in clinical research, as well as how digital technologies can enable personalized medicine.

Le Song, Chief Advisor for Medidata Product Solutions at Dassault SystèmesThe presentation underscored the critical importance of patients’ genuine needs in clinical research, analyzing the determinants, preferences, and experiential feedback related to patient participation. She stated that only by gaining a deep understanding of patients’ true needs can more precise clinical diagnostic information be obtained, thereby addressing the many challenges encountered in clinical research. Building on this insight, Medidata launched the myMedidata patient platform, which covers all stages from pre-trial to post-trial phases. The aim is to leverage these digital tools to enhance patient engagement, reduce the burden of participation, and improve patients’ overall experience in clinical research. “Our goal is to establish mutual trust with patients and view them as integral partners in clinical research, rather than merely as subjects, so that we can better guide their participation,” said Le Song.

Song Le, Chief Advisor for Dassault Systèmes Medidata Product Solutions

Traditional clinical research processes have evolved over a century. Despite the continuous advancement of automation and digitalization in internal corporate workflows, core processes remain predominantly manual, leading to a series of severe challenges in the operational and data management aspects of traditional clinical development. First, manual operations can result in data entry errors and an inability to trace source data, thereby compromising data authenticity and integrity. In particular, the manual transcription of clinical research data from hospital systems into corporate Electronic Data Capture (EDC) systems is prone to numerous entry errors and discrepancies. Meanwhile, various data quality issues arising during clinical operations generate increased data queries and corrections, resulting in significant waste of manpower and delays in database lock. To some extent, this has also contributed to the rising costs of clinical research in China.

Purui’s positioning is to leverage AI-driven digital technologies to reshape the core value chain of clinical R&D. Committed to optimizing clinical research processes through AI technology and achieving automation, Purui aims to build a localized, digital, and intelligent clinical research platform tailored to China’s specific context, thereby enhancing the speed and quality of research.

At the conference, Dr. Wang Zheng, Founder & CEO of Purui and Senior Advisor to the President of IQVIA Asia PacificOn-site Launch of Digital Intelligent Clinical R&D Solutions。According to the introduction, this solution covers the entire process from pre-market clinical studies to post-market indication expansion, aiming to enhance the value of drugs within their limited patent cycles through AI technology, reduce R&D costs, and accelerate patient access.

Dr. Wang Zheng, Founder and CEO of Purui, Senior Advisor to the President of IQVIA Asia Pacific

This solution comprises two core products: the eSource-to-EDC (E2E) clinical operations platform and the Decentralized Clinical Trial (DCT) patient-centric clinical trial platform. It aims to achieve end-to-end automation in clinical research, thereby enhancing data accuracy and study efficiency. Dr. Wang Zheng introduced four key innovations of the solution. First, by tracing the source of clinical trial data back to hospitals, it ensures the quality of source data at the hospital level and enables automated data collection with direct machine entry into the EDC system. Second, the platform transforms the traditional monitoring model, shifting from a single, retrospective approach heavily reliant on Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs) to a comprehensive process management framework covering pre-event, during-event, and post-event stages. Third, PuRui has launched next-generation EDC solutions driven by E2E integration, along with intelligent disease-specific database solutions. Fourth, leveraging the eSource-to-Pharmacovigilance (E2P) intelligent pharmacovigilance system based on AE/SAE smart monitoring and source data quality assurance, as well as the Imaging and Pathology Analysis (iRC) solution, the platform achieves automation and intelligence in clinical research data. This safeguards the accuracy and efficiency of clinical study data, accelerating the overall improvement in quality and efficiency of clinical research in China.

“With this solution, Purui aims to reduce labor costs for CRCs and CRAs by 70%, lower total clinical research expenditures by 45%, and accelerate processes by 30%. ‘Our early pilot projects have already demonstrated this, achieving significant efficiency gains by reducing manual hours and R&D costs. Looking ahead, we aspire for Purui to become a leader in clinical research and development in China and globally, and we invite partners from within and outside the industry to engage in dialogue and collaboration to drive sector advancement,’ said Dr. Wang Zheng.”

At the conference, Purui announced the establishment of multiple strategic collaborations, committed to further deepening horizontal cooperation and vertical development of its digital and intelligent clinical R&D solutions. Notably, Purui declared a strategic partnership with Medidata, aiming to deeply integrate cutting-edge technologies with Chinese market demands and drive their practical implementation, building upon technological innovations and best practices in global clinical research.

PRIME & Medidata Signing Ceremony

Dassault SystèmesMs. Li Wei, Vice President of Medidata Life Sciences, General Manager of Greater China, and Head of APAC International CRO Business Development, along with her team; Dr. Wang Zheng, Founder and CEO of Prime Medicine, along with his team; and Dr. Mi Zihou, President of IQVIA Asia Pacific, attended the on-site signing ceremony.

Meanwhile, PuRui officially announced its strategic investment and commercialization partnership with IQVIA Health Industry Investment in digital innovation for clinical trials, its collaboration with the Suzhou High-Tech Zone Global Radiology and Pathology Imaging iRC Innovation Center, and its deep strategic cooperation between PuRui E2E and the IQVIA DCT platform.

Signing Ceremony between Purui, Quintiles (Hefei) Health Industry Fund / Suzhou High-Tech Zone, and IQVIA

With the booming development of innovative drugs worldwide, the demand for clinical research in pharmaceuticals is growing day by day, and the market continues to expand.

Opportunities are accompanied by crises: clinical research involves multi-party collaboration, yet communication efficiency between sponsors and service providers remains low; information silos persist; issues regarding the quality and integrity of clinical data urgently need to be addressed; and there is a lack of comprehensive solutions for the integrated management of hospital-based clinical research. Faced with these challenges, how can we ensure that all stakeholders collaborate effectively to drive genuine digital and intelligent transformation, achieving true “mutual alignment and synergy”?

At the conference, multiple participants shared their practical experiences in digital and intelligent transformation from their respective perspectives. Among them,Wu Jiancai, Deputy Director of the Scientific Research Department, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and TechnologyHe shared insights on “Construction of High-Level Research Wards and Exploration of Digital Innovation,” showcasing Peking Union Medical College Hospital’s proactive efforts in clinical research and digital innovation. He emphasized that informatization plays a pivotal role in clinical research, enhancing research efficiency and the quality of data management. By integrating disparate systems, end-to-end digital management across the entire project lifecycle will also be achieved. Director Wu expressed strong confidence in the hospital’s future digital development, looking forward to further improving the quality and efficiency of clinical research through data mining, intelligent quality control, and comprehensive end-to-end data support.

Wu Jiancai, Deputy Director of the Scientific Research Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Jiang Yanmin, Senior Vice President of Harbour BioMedIn her keynote speech titled “Exploration and Prospects of Risk-Based Monitoring (RBM) Empowered by Digital Technologies,” she introduced the underlying logic of RBM and the challenges encountered during its implementation. She noted that digital and intelligent technologies provide robust technical support and data assurance for clinical research, significantly enhancing research efficiency. As a valuable tool in clinical research, RBM still faces numerous challenges in its current implementation. Risk assessment, data monitoring, and dynamic monitoring are key to the successful implementation of RBM, while the application of digital technologies helps improve the efficiency and quality of clinical monitoring.

Harbour BioMed Senior Vice President, Yanmin Jiang

Mao Shuo, Executive Director at Qiming Venture PartnersFrom the perspective of investment institutions, he shared insights on “Investment Opportunities in Digital and Intelligent Clinical Trials.” He noted that clinical trials are the most critical and costly phase of drug development. Leveraging digital tools to enhance trial efficiency, reduce costs, and improve quality will create substantial market opportunities. Although there are relatively few companies in China focused on innovation in clinical trials, the market is evolving, with a growing need to apply digital technologies to optimize existing clinical trial processes. AI technologies, particularly large language models, hold significant potential in healthcare by playing a crucial role in processing unstructured data, interpreting clinical data, and screening and enrolling patients.

Qiming Venture Partners Executive Director Mao Shao Delivers Online Presentation

To further deepen discussion and exchange among all stakeholders, the roundtable session was moderated by Director Shen Yifeng of the Shanghai Mental Health Center. Participating experts engaged in further deliberations on the theme “Digital Intelligence Empowerment and Mutual Engagement: Considerations, Explorations, and Collaboration Among All Parties Involved in Clinical Research Regarding Digital Transformation.”

Roundtable Discussion

Experts at the conference stated that innovation must be rooted in clinical needs and closely aligned with actual requirements from the early stages. Meanwhile, an open mindset should be maintained toward emerging technologies, advancing their application and development through continuous iteration and rapid experimentation. The experts also particularly emphasized the importance of early communication regarding needs, as well as achieving simplified workflows and significantly improved efficiency through standardized interfaces.

In this process, the application of digital tools is crucial for enhancing the efficiency and quality of clinical research. “As digital transformation advances, our understanding of quality will also evolve. Traditionally, we pursued ‘right first time,’ meaning meeting expected standards on the initial attempt. However, in today’s increasingly digital landscape, our quality requirements extend beyond this; we must also focus on how to improve efficiency while ensuring quality.”

It is worth noting that data security and openness are the core pillars of digital-intelligent transformation. It is reported that numerous hospitals and research institutions are committed to establishing big data centers to strengthen data governance, ensuring more efficient and secure utilization of these data in the future.

From its essence, the implementation of digital and intelligent transformation represents the most significant driving force for enhancing productivity at the current stage of human development. In the future, we look forward to achieving the digital and intelligent transformation of clinical research through interdisciplinary and cross-sector collaboration among multiple stakeholders, thereby significantly improving the quality and efficiency of research and delivering faster, more precise treatment options to patients.