AuroraPrime Clinical Research Platform by AlphaPrime Health Tech Breaks Through Industry Pain Points with Proprietary Clinical Logic Engine
In recent years, competition in the critical domain of clinical research has intensified, with costs rising annually. Furthermore, as many clinical trials span multiple centers, platforms, countries, and clinical phases, they exhibit high complexity, prolonged timelines, and elevated risks. These represent common challenges and pain points facing this sector.
The development of clinical management systems is typically aimed at addressing these pain points, with the goal of improving efficiency and reducing costs.
In the view of Chen Xiao, Co-CEO of Yacheng Health Technology, many industry participants have identified the pain points; the key lies in distilling a product concept from these insights and realizing it through engineering capabilities. “While there are already numerous pioneers in China developing clinical management systems, the demands driving the industry’s robust growth are multifaceted. It is no longer just about data collection and entry; what is now needed is the implementation of unified informatization and intelligence across the entire clinical trial process.”
In this regard, Yaosheng Health, a clinical research cloud platform developer founded less than a year ago, has delivered an impressive performance. In May 2021, AuroraPrime Clinical Research Platform V1.0, developed by Yaosheng Health, was officially launched and began serving its first batch of clients.
Unlike other existing clinical research management systems, the AuroraPrime platform has been designed from the ground up with its underlying frameworkProvides a series of comprehensive, interconnected functional modules that form a complete value chain, while incorporating a powerful clinical logic engine., redesigned the system platform for the future to accommodate the rapid development of modern clinical trials, enhancing its scalability and adaptability,Achieved a balance between operational efficiency and data quality in clinical trial operations management.
The life sciences innovation sector served by HealthX currently enjoys rapid growth in China, with its ecosystem primarily comprising clinical trial sponsors and contract research organizations (CROs). As a software system provider in this highly specialized niche, HealthX continues to implement cutting-edge technologies in the field of clinical trials. Under strict compliance frameworks, it empowers sponsors and CROs to explore and advance life sciences innovation through intelligent, user-friendly clinical research tools.
Clinical trials represent the final hurdle that a drug must clear before market approval, with their success or failure directly determining whether the medication can ultimately be commercialized. Consequently, pharmaceutical companies place immense importance on clinical trials, sparing no effort in allocating resources to ensure their smooth execution.
In recent years, with the leapfrog development of the biopharmaceutical industry, Contract Research Organizations (CROs) have increasingly become the most prominent concept and business model in the sector. For instance, in November 2017, Pharmablock Sciences listed on the ChiNext board and its share price quickly surpassed RMB 100; in May 2018, WuXi AppTec returned to the A-share market, becoming a unicorn company.
Over the past decade, the global pharmaceutical market has entered a period of “patent cliffs,” which has been a key driver behind the rapid growth of contract research organizations (CROs). According to statistics from EvaluatePharma, patent cliffs will result in $79 billion in sales losses for global pharmaceutical companies between 2016 and 2020. Sales of drugs whose patents have expired accounted for 3.67% of total sales, and this factor is expected to impact the sales revenues of major pharmaceutical companies worldwide by varying degrees ranging from 5% to 72% in the coming years.
Amid the impact of large-scale patent expirations on pharmaceutical companies’ revenues, there is an increasingly urgent need for these firms to identify new drug candidates, accelerate R&D pace, and shorten the approval timeline for new drugs, thereby striving to secure greater first-mover advantages. However, developing new products is by no means easy; it is not only technically challenging and costly but also entails a protracted time cycle.
According to data from the Tufts Center for the Study of Drug Development, the average cost of developing a new drug has risen from approximately $180 million in the 1970s to $2.6 billion in the early 21st century. Meanwhile, the success rate for new drugs advancing from Phase I clinical trials to market approval has declined from 23% in the 1980s to 12% currently.
It is against this backdrop that the Contract Research Organization (CRO) model has emerged. By decomposing R&D processes, outsourcing not only reduces costs but also enhances efficiency.
Based on the agreement between Astellas, Japan’s second-largest pharmaceutical company, and CRO firm INC Research, it is predicted thatThrough collaborative agreements, R&D costs can be reduced by up to 40%, while clinical research time is shortened by 10%–20%.According to market statistics, pharmaceutical companies can shorten their R&D timeline by approximately 25% by outsourcing clinical trials to CROs. Based on Tufts data, the involvement of CROs can reduce the duration of the four clinical stages—Phase I, Phase II, Phase III, and NDA review—by 23, 58, 43, and 31 weeks, respectively, lowering the total time from 497 weeks to 342 weeks.
The Significant Value of CROs in New Drug Development Drives Rapid Industry Growth. In 2020, the global CRO market size exceeded $60 billion, while the domestic market in China reached nearly $8.3 billion.From 2011 to 2015, the global CRO industry recorded a compound annual growth rate (CAGR) of 8.25%. From 2014 to 2018, the CAGR of China’s CRO industry was 27.4%, surpassing the global average.
However, amid rapid development, the CRO industry encountered a downturn in 2015 due to factors such as companies’ need to enhance their technical capabilities, disorderly market competition, and inadequate regulatory oversight. On July 22, 2015, the China Food and Drug Administration (CFDA) issued the “Announcement on Launching Self-Inspection and Verification of Drug Clinical Trial Data.” Against the backdrop of stringent regulatory crackdowns on falsified clinical trial data and non-compliant clinical trials, a total of 1,622 drug products were subject to clinical data verification that year; among them, 1,165 applications were voluntarily withdrawn, and 40 were either rejected or returned for further review, resulting in a failure rate exceeding 74%.
Additionally, under the impact of the COVID-19 pandemic, the conduct of clinical trials other than those for COVID-19 has faced significant obstacles.Comprehensive isolation measures have severed physical contact between researchers and participants, significantly impacting patient follow-up, medication dispensing, and compliance. These disruptions have profoundly affected the cost-efficiency of clinical research, while further increasing the complexity and risks associated with clinical trials.
In recent years, with the development of the internet, big data, and artificial intelligence, various sectors of the biopharmaceutical industry are actively undergoing digital transformation, including AI-driven drug discovery, digital therapeutics, digitization of clinical trials, clinical data mining, electronic health records (EHR), real-world studies, pharmacovigilance, and market analysis. The digital clinical trial ecosystem, built on tools such as CTMS, EDC, ePRO, and PV systems, enables online information flow between subjects and investigators, ensuring the steady progress of clinical trials during the pandemic.
For the CRO industry, digitalization and online integration are also effective ways to address the development challenges faced by CRO companies. In addition, they significantly reduce the risks and costs of clinical trials while improving their efficiency.
In mid-2019, a leading company in the upstream digital CRO sector was acquired for $5.8 billion (approximately RMB 41.2 billion at the current exchange rate), indicating that the industry had already achieved a certain scale. The pandemic further accelerated this digital transformation. Empowering clinical research with digital technologies has become a trend, not only in drug development but also in other R&D fields.
Yaocheng stated that, as a developer of cloud-based platforms for clinical research informatics, it is building a SaaS platform to serve life sciences clinical research, covering the entire R&D value chain in the life sciences sector. The company aims to become a key partner for sponsors and CROs in further advancing the digitalization of clinical research.
Unlike other existing clinical research systems, the AuroraPrime platform developed by Medicengines incorporates its proprietary “Clinical Logic Engine” as a unified foundational infrastructure.From the ground up, Yaosheng’s framework was designed to enable seamless and efficient interconnectivity among its various functional modules, allowing information to transcend different dimensions. This enhances the efficiency of trial design and execution, provides real-time status visibility, optimizes collaboration, and reduces costs.
The “Clinical Logic Engine” serves as the “brain” of the AuroraPrime platform. To address the efficiency and cost challenges inherent in clinical research, the Auroramed team designed a comprehensive system logic from the underlying framework. With consideration for future scalability, forward-thinking capabilities, and internationalization, the team positioned its product services from a global, macro-level perspective, rather than adopting a modular product design approach focused on isolated issues or needs. Ultimately, the Auroramed team distilled the core concept of the “Clinical Logic Engine,” establishing an integrated, intelligent, and internationally oriented platform design philosophy.
Chen Xiao introduced that the primary objective of the “Clinical Logic Engine” is to achieve a profound understanding of clinical trials by leveraging extensive clinical trial data. By employing the system’s “brain” to deeply comprehend the logical relationships among various elements and multidimensional data, it ultimately drives the efficient conduct of trials and facilitates seamless data flow.It spans the entire spectrum of clinical research, encompassing critical clinical trial data as well as related dimensions such as personnel, documentation, operations, and compliance.The “Clinical Logic Engine” comprehends the intrinsic logic and interdependencies among various dimensions and processes, taking a holistic view to define clear objectives for optimized collaboration. Based on this automated structuring, the “Clinical Logic Engine” can more efficiently support operational management throughout the entire lifecycle of clinical trials.
Chen Xiao stated that the Yaosheng team, drawing on its deep industry expertise and guided by a spirit of craftsmanship, has been meticulously refining and building this product from the outset. Aiming to create a platform capable of serving the industry over the long term, the Yaosheng team devoted considerable time to planning and establishing the underlying infrastructure, integrating the team’s profound insights into computer science with specialized knowledge and experience in life sciences clinical trials. As a result, what Yaosheng has created“The Clinical Logic Engine” continuously learns and accumulates knowledge on clinical trial scenarios, workflows, designs, and data. Through iterative upgrades, it will truly evolve from a mere tool into a trial “assistant.”
On May 20, 2021, AuroraPrime V1.0 by Yaosheng was officially launched in Suzhou.
Leveraging the “Clinical Logic Engine,” the AuroraPrime platform enables “intelligent, integrated, and internationalized” capabilities.In terms of integration, first, it refers to the integration of the management platform. Starting from the underlying framework, the AuroraPrime platform achieves full-link penetration rather than mere module connectivity, thereby holistically and macroscopically optimizing the entire clinical research process and managing its full lifecycle. Second, it refers to global integration, which also encompasses Yuncheng’s international deployment strategy, addressing the conflicts between global standardization and local adaptation. Yuncheng has implemented internationalized designs across regulations, performance, analytics, management, language and localization, and cloud compatibility, thereby enhancing the adaptability and scalability of the AuroraPrime platform. Intelligence refers to leveraging the “Clinical Logic Engine” to understand the intrinsic logic and interdependencies among different dimensions and processes of clinical research, taking a comprehensive approach to define and optimize collaborative objectives.
“Achieving such a design requires technical capabilities and meticulous handling of technical details across multiple stages, including algorithms, modeling, logic integration, and real-time data storage, retrieval, and protection,” Chen Xiao explained. She repeatedly emphasized the concept and role of the logic engine.By establishing a robust framework and leveraging the logical interplay among its components to support diverse business scenarios—including the flexible combination of various functional modules—we unlock greater long-term application potential. This also lays a solid foundation for rapid system iteration and functional scalability.
In addition, Chen Xiao stated,Although Yaosheng has not yet launched its international deployment, the clinical systems it has developed possess leading internationalization capabilities, along with cutting-edge and comprehensive design philosophies.If a company adopts a multi-cloud adaptation system, it can deploy services on both Chinese and U.S. cloud platforms, all built upon the same comprehensive logical framework.
The company has currently established collaborations with firms including InnoX Therapeutics and Pharmaron Clinical, and the AuroraPrime platform has received positive feedback from its launched clients.
Yaocheng is a company with strong Google DNA, as its founders and many executives are former Googlers. Having undergone Google’s comprehensive technical training, they possess a global perspective and development mindset aligned with cutting-edge technologies. Consequently, during the early stages of product development at Yaocheng, the team prioritized a concise, flexible, secure, and reliable underlying architecture, along with an excellent user experience.
Mr. Xu Pengcheng, Co-founder, Chairman, and Co-CEO of Medtrio, was Google China’s first locally hired engineer and formerly served as Chief System Architect at Verily Life Sciences China (Verily, a life sciences-focused startup under Alphabet, Google’s parent company). Ms. Chen Xiao, the other Co-CEO, spent 15 years at Google, where she previously served as Head of Google Research Shanghai and General Manager of Verily Life Sciences China.
Rui Li’s professional experience gradually acquainted Yaosheng’s founding team with the pharmaceutical and healthcare sector, planting the seeds for their entrepreneurial venture. After observing that Rui Li encountered new bottlenecks in China, they realized that their own approach to entrepreneurship might be more effective. Consequently, they established Yaosheng in early August 2020.
During their tenure at Ruili, the founding team of Yaosheng observed a surge in global demand for clinical research, with China maintaining an annual growth rate of 20%–30%. Furthermore, compared to other industries, there is significant room for improvement in the overall software capabilities within this field.
Combining market demand with its own capabilities, Yaosheng chose to develop a clinical research platform after its establishment.
In addition to the Google-affiliated team members, the company’s founding team includes seasoned experts in the life sciences sector. Mr. Zhang Zhi, former Head of Channel for Medidata’s Asia-Pacific region, oversees business-related operations. Ms. Xu Ronghuai, who brings over 15 years of industry experience from leading global CROs including IQVIA, Covance, WuXi Clinical, and PPD, leads the clinical services team. The team also comprises talent from life sciences companies such as Merck & Co., Novartis, WuXi AppTec, and GE Healthcare, as well as software and computer specialists from internet and technology firms including Microsoft, Splunk, ByteDance, and Tencent.
On July 22, 2021, Yaosheng Health officially completed its Series A financing round of over RMB 100 million, thanks to the team’s concerted efforts.This round of financing was led by the Shanghai Artificial Intelligence Industry Investment Fund (hereinafter referred to as “Shanghai AI Fund”), with participation from Lightspeed China Partners, Hankang Capital, Legend Star, and Chunhua Venture Capital. This marks Yaocheng’s second funding round this year, following a seed round that raised tens of millions of yuan. Lightspeed China Partners and Hankang Capital, investors in this round, also participated in Yaocheng’s seed round.