Bio-Data Intelligence: Empowering China's Pharmaceutical R&D 2.0 Era with Integrated Informatics and AI

Around 2007, SaaS platforms officially entered the cloud computing era. Not only did Alibaba enter the fray, but companies such as Microsoft and Oracle also began to strategically position themselves in the SaaS market. It was also in this year thatSaaS services in the life sciences vertical are also on the rise.

That same year, Zhuang Yonglong, who had earned his Ph.D. from Tsinghua University more than three years earlier, resigned to embark on an entrepreneurial journey, co-founding bioknow with his partner Liu Guangyu. Over the past decade-plus, the life sciences informatics industry has evolved from a dormant state to a period of explosive growth. After more than ten years of deep engagement in the field of life sciences R&D, bioknow has weathered the industry’s ups and downs. Nevertheless, the company’s original mission and future roadmap have remained unchanged: to build an integrated platform.

When bioknow was founded, the life sciences informatics industry was still in a trough, with low market penetration in China. The domestic understanding of clinical data management was superficial, and there were no regulatory policies in place. It could be said that this was not the ideal time to enter the market. However, based on his specialized expertise in life sciences informatics and his insight into market pain points, Zhuang Yonglong decided to take a bold leap.

He told VCBeat (WeChat ID: vcbeat) that his original motivation for starting a business was quite simple: “With my background in bioinformatics, after three years of work, I felt there were not many products in this industry. My initial idea was straightforward—to provide a software solution for a client’s drug R&D laboratory to help them establish a laboratory R&D management system, which proved highly successful at the time. Later, I continuously participated in and led multiple major national projects under the 10th, 11th, and 12th Five-Year Plans.”

Since its establishment, bioknow has weathered an industry winter. The year 2015 marked a watershed moment for the entire life sciences informatics sector, shifting the industry from gradual penetration to rapid, iterative growth. On the policy front, the 2015 announcement by the China Food and Drug Administration (CFDA) on self-inspection and verification of clinical trial data significantly enhanced the standardization of clinical trial data and project process management in China. This was followed in July 2016 by the issuance of the Technical Guidelines for Electronic Data Capture in Clinical Trials, which delivered a substantial impact on clinical trial data collection. Subsequently, Order No. 18 mandated that all pharmaceutical manufacturers establish pharmacovigilance systems. In June 2017, the CFDA officially joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), signaling that domestic regulatory oversight of clinical trial data and processes would align with international standards.

Secondly, within the industry, there is an emerging shift from the traditional strategy of expanding product lines to building integrated platforms. Bioknow is the pioneer of the “one portal, one account, one system, one-time entry” integrated platform. Currently, Bioknow has successfully developed China’s first integrated information platform for pharmaceutical research with independent intellectual property rights.

Recalling the early days of his entrepreneurial journey, Zhuang Yonglong stated, “Through continuous engagement in the pharmaceutical industry and observations of clinical trials conducted by Chinese pharmaceutical companies, I conceived an idea: Could we develop an integrated platform that encompasses all software products required for clinical research? Customers could adopt individual modules or use them in combination, enabling centralized management of all project information, minimizing cost increases and time waste caused by human factors, and thereby shortening the overall cycle of clinical trials.”

Due to the large number of stakeholders, long duration, and highly complex processes involved in clinical trials, coupled with stringent requirements for data integrity and regulatory compliance, current market solutions are designed to address key needs within clinical trials. For instance, Electronic Data Capture (EDC) systems primarily resolve issues related to clinical trial data acquisition and collection, replacing traditional paper-based methods that were characterized by slow data capture and poor data quality. Meanwhile, Pharmacovigilance Systems are used to collect drug safety information and facilitate regulatory reporting through automated system submissions.

In terms of its standalone product portfolio, bioknow already offers more than 10 products, including an Electronic Data Capture (EDC) system for clinical research, a Pharmacovigilance (PV) management system, an electronic Trial Master File (eTMF) system for comprehensive clinical trial documentation, a Clinical Trial Management System (CTMS), a Randomization and Trial Supply Management (RTSM) system, a Clinical Data Total Management System (CDTMS), an intelligent medical coding system (Medcoding), an online training and assessment system (eTraining), and a Pathology Data Management (PDM) system for clinical trial image reading and specimen transport. These solutions cover every stage of the end-to-end process, from clinical trial data collection to post-marketing safety data monitoring.

In line with its strategy to build an integrated platform, bioknow has integrated more than 10 products into its one-stop cloud platform for clinical research, eClinical. In addition, bioknow has developed another major cloud platform—the MedAI Intelligent Pharmaceutical Research Cloud Platform, which comprises the MedAI Intelligent Topic Selection, MedAI Intelligent Reporting, MedAI Intelligent Data Analysis System, and MedAI Journal Recommendation System. The MedAI Cloud Platform empowers researchers in topic selection and project initiation, research data analysis, and scientific paper publication, while also helping corporate medical affairs departments achieve intelligent management of investigator networks, thereby establishing an intelligent collaborative platform for pharmaceutical research.

Why Bet on an Integrated Platform? Zhuang Yonglong Explained: “Because pharmaceutical research is a relatively complex business system, and each segment currently has corresponding software products to address issues within that specific link. However, there are many commonalities and data interoperability needs across different business segments. Therefore, the most critical aspect of an integrated strategy is to resolve data interoperability and information cross-referencing. This is precisely why we chose to integrate the entire product suite.”

And the differentiated choices made at that time have been proven correct by the passage of time.

Over the past decade, bioknow has served more than 1,000 clients. Its products have been utilized in over 2,300 drug or medical device projects that are undergoing or have completed clinical trials. More than 180 hospitals have adopted the bioknow platform to record and collect clinical trial data, with a cumulative total of 600,000 trial participants served by bioknow.

As the number of players in the life sciences informatics sector continues to grow, industry competition has intensified further. Currently, in addition to informatics vendors, some CRO companies have also entered the market, and even certain foreign enterprises are beginning to expand into the Chinese domestic market.

Zhuang Yonglong stated bluntly that competition is inevitable. Drawing from the more mature U.S. market, he noted that only three companies are likely to remain in the end. He also expressed confidence in bioknow’s ability to develop products on par with international offerings, while maintaining a price advantage.

Although SaaS services for the life sciences industry lean toward the IT sector, designers of life sciences informatics solutions must be teams with long-term engagement in and research on clinical trials, possessing a deep understanding of clinical trial business processes. Currently, after successfully raising tens of millions in financing, bioknow has introduced talent with extensive experience in the life sciences industry across all operational areas.

“We have made significant efforts to standardize and professionalize every aspect of our operations. Although this process of self-reform is challenging, it is beneficial to our long-term development,” said Zhuang Yonglong.

The life sciences informatics sector was previously favored due to the release of policy dividends; in the future, Zhuang Yonglong believes that market growth will be driven by the development of China’s life sciences industry.

Zhuang Yonglong stated, “The entire life sciences informatics industry is undergoing continuous change. Driven by certain policy initiatives, pharmaceutical companies may experience significant mergers, acquisitions, and transformations. The number of pharmaceutical companies in the future may be lower than it is today. The primary growth drivers in the market will come from large pharmaceutical companies and emerging biotechnology firms, because life sciences customers rarely switch suppliers. This creates high barriers to entry for new competitors, while established companies must possess a global perspective.”

How to Navigate the Intensifying Market Competition. Zhuang Yonglong also revealed that bioknow will focus on three strategic directions for its future product development. First, centered on informatization in pharmaceutical research, the company aims to make its products covering the entire spectrum from clinical trials to post-marketing processes more internationalized and intelligent, thereby meeting the growing requirements for innovative drug submissions by R&D enterprises both domestically and internationally. Second, it will strengthen the competitiveness of its MedAI product, enabling more researchers to conduct scientific and clinical studies quickly and conveniently. Third, in the data services product line, bioknow will leverage AI technologies and collaborate with senior experts both within China and abroad to deepen the integration and mining of pharmaceutical big data, providing more convenient, efficient, and effective data analysis solutions. This will help propel China’s pharmaceutical research into the 2.0 era, characterized by greater intelligence and professionalism.