Medidata Empowers Clinical Trial Digitalization with AI, Supporting Over 34,000 Trials and 10M+ Patients

No one would deny that artificial intelligence has now become an indispensable part of healthcare.

Leveraging techniques such as machine learning and deep learning, artificial intelligence (AI) has already played a significant role across the entire drug development lifecycle, including drug discovery, preclinical research, and clinical trials. Since its early exploratory phase in 2007, AI-driven drug development technology has progressed through stages of technological accumulation, validation, and rapid growth, arriving at a current phase characterized by vibrant technological innovation, substantial policy support, and broad market prospects.

In September 2024, the 13th Medidata NEXT China Annual Conference was held in Shanghai, bringing together more than 600 global life sciences elites to explore how AI and decentralized clinical trials (DCTs) can empower future clinical trials. The conference illustrated the answer by showcasing how innovative technologies and solutions are reshaping the clinical trial landscape and accelerating the availability of new therapies.

As a wholly owned subsidiary of Dassault Systèmes, Medidata has been both an innovator and witness to advancements in clinical trial digitalization and AI technology. It maintains close collaborations with domestic pharmaceutical companies in China, facilitating progress in clinical trials. As of September this year, Medidata had established partnerships with more than 2,200 clients across over 140 countries and regions worldwide, supporting more than 34,000 clinical trials and engaging over ten million patients globally. Notably, last year Medidata contributed to 65% of the new drug applications approved by the U.S. Food and Drug Administration (FDA), with this figure reaching as high as 93% in the field of oncology.

During the event, VCBeat conducted interviews with Anthony Costello, CEO of Medidata, a Dassault Systèmes company, and Li Wei, Vice President of Medidata and Life Sciences at Dassault Systèmes, General Manager for Greater China, and Head of APAC International CRO Business Development. The discussions aimed to clarify Medidata’s strategic leadership path and explore industry trends.

From 2013 to 2023, China’s pharmaceutical industry experienced a golden decade of rapid development, during which the proportion of globally conducted clinical trials led by China rose significantly from 3% to 28%. By 2023, the number of innovative therapies approved for market launch by Chinese regulatory authorities exceeded 40, reaching a record high. Meanwhile, an increasing number of Chinese innovative pharmaceutical companies are expanding onto the global stage, with the number of out-licensing deals in 2023 surging by 88% year-over-year, also setting a new record.

However, challenges have continued to intensify. Notably, from 2020 to 2023, capital investment in innovative drug R&D plummeted by 70%, exerting a profound impact on the capital-intensive pharmaceutical R&D sector. Although the average annual number of clinical trial initiations remained stable at a high level of approximately 1,000 over the past three years, the number of high-quality global multi-center clinical trials declined rapidly, dropping by 38% between 2022 and 2023. Moreover, the recovery has fallen short of expectations, exhibiting a sustained downward trend.

“Innovation Without Borders, Moving Forward Toward the Light.” As stated in the theme of the Medidata NEXT Annual Conference, Medidata is leveraging digital innovation to support Chinese pharmaceutical companies in navigating the current challenges and helping domestic enterprises expand into markets across China and around the world.

Li Wei emphasized that a series of policies issued by the government in recent years have actively promoted the digital and intelligent transformation of innovative drug R&D, sending positive signals to the industry. However, China’s pharmaceutical R&D sector is currently facing the severe challenge of a “capital winter,” making it particularly urgent to rapidly launch optimal products in the critical “arena” of clinical trials. To this end, the primary task for enterprises is to achieve cost reduction and efficiency enhancement, with the core of improving efficiency lying in the adoption of high-quality, trustworthy technical solutions. Medidata is actively seeking to apply cutting-edge technologies in the Chinese market, combining global experience with local practices to help enterprises reduce costs and improve efficiency in a practical and effective manner.

Furthermore, as a vital component of Dassault Systèmes’ Life Sciences portfolio, Medidata is not only dedicated to enhancing the efficiency of clinical trials but also collaborates closely with brands such as BIOVIA to provide innovative strategies for the industry. By leveraging cutting-edge technologies, Medidata optimizes the entire life sciences workflow—from preclinical research and clinical trials to manufacturing—ensuring the efficient advancement of innovative therapeutic programs. This includes employing advanced technologies to boost research efficiency and actively aligning with the Chinese government’s initiative on “new quality productive forces.” Through intelligent, high-quality R&D strategies, Medidata fully leverages China’s vast population base and complex healthcare system to accelerate new drug development and facilitate the rapid entry of pharmaceuticals into global markets.

Subsequently, Anthony Costello further shared insights on Medidata’s business development, emphasizing from a practical application perspective the company’s multiple innovations in AI-enabled digitalization and intelligence of clinical trials. These include AI-driven study design, planning, and execution; breaking down data silos through a unified digital platform to enhance process efficiency and support critical decision-making; and leveraging DCT (Decentralized Clinical Trials) technology to reduce patient burden and improve patient engagement experiences.

Anthony Costello believes that, as the global clinical research industry seeks more innovative paradigms, Medidata aims to break with tradition and revolutionize the patient experience by enabling data collection across the entire patient journey, while also expanding data sources to provide more comprehensive and robust data support for clinical research. This approach drives innovation in research paradigms by enhancing trial experiences and operational models.

To enhance the patient trial experience, Medidata has launched myMedidata. This mobile application enables patients to enter data from home, facilitating remote participation in clinical trials. Furthermore, Medidata encourages the use of technologies such as wearable sensors. By continuously collecting patient data through these sensors, researchers gain a more real-time and comprehensive view of patient status. The value of this data surpasses that traditionally obtained through form completion and extends across various aspects of clinical research.

Medidata’s newly launched Clinical Data Studio provides enterprises with effective solutions for digital asset management, cost reduction, process simplification, and efficiency enhancement.

Medidata Clinical Data Studio leverages artificial intelligence to efficiently integrate data from multiple sources, delivering high-quality insights for clinical trials. With Clinical Data Studio, data managers can automate data quality management, while study teams can rapidly gain insights into trial data to address challenges.

Medidata has also made significant strides in generative AI technology. Anthony Costello believes that future clinical trials will increasingly rely on generative AI applications. By leveraging generative AI, synthetic or virtual patients can be created based on historical patient data, thereby reducing the risk of exposing real patients to unnecessary participation in future studies. Medidata is poised to seize the opportunities presented by AI, driving further digital innovation in clinical trials and ultimately realizing the future vision of virtual twins in life sciences.

Looking ahead, Medidata will continue to address unmet clinical needs through digital and intelligent innovation strategies. By leveraging advanced technologies and methodologies such as artificial intelligence (AI) and decentralized clinical trials (DCTs), Medidata aims to help clients make more informed decisions on R&D pathways, accelerate drug approval processes, foster the growth of Chinese pharmaceutical companies in the domestic market, and support their global expansion.