Siluxin Files IPO Prospectus to Become the Most Doctor-Centric EDC Provider in Clinical Trials

EDC System (Electronic Data Capture System for Clinical Trials) is an information system designed for clinical trials, enabling multi-center data collection through web-based data entry. In the United States, over 80% of clinical trials now utilize EDC systems. According to survey data from VCBeat, the adoption rate of EDC systems in China remains below 50%.

In recent years, the research and development of innovative biological drugs in China has continued to heat up, generating a vast amount of case data from numerous clinical trials. However, traditional clinical research data collection still relies on paper records or Excel spreadsheets, resulting in inconsistent data quality that is difficult to use directly for clinical analysis and fails to meet the progress management and quality control requirements of multi-center studies. Since 2015, China has introduced a series of policies to promote the application of Electronic Data Capture (EDC) systems, aiming to encourage the adoption of EDC systems in clinical research and standardize their functionalities. Meanwhile, EDC systems may also be utilized by regulatory authorities for review during drug approval processes in the future.

Traditional Research Data Collection Process

S-Luxin is research-driven, focusing on the independent development of an all-in-one Electronic Data Capture (EDC) system that serves major Grade 3A hospitals, research institutions, and Contract Research Organizations (CROs), covering the entire clinical trial process. “Our goal is to establish a research database for every clinical investigator,” said Zhao Guang, CEO of S-Luxin, in an interview with VCBeat News.

Before founding the Yirui EDC system, Zhao Guang studied at Tongji Medical College of Huazhong University of Science and Technology and later worked at Merck & Co. Through interactions with physicians, Zhao identified their data analysis needs in conducting multicenter clinical trials. Although some hospitals were equipped with foreign EDC systems, these solutions were costly and inconvenient to use.

“The domestic EDC market is more focused on large CRO companies and pharmaceutical firms, with no usage scenarios tailored for physicians.” In late 2014, Zhao Guang left Merck & Co. to become the CEO of Siluxin, where he developed the Yirui EDC system and subsequently participated in dozens of research projects, including the National Key R&D Program, the 13th Five-Year Plan initiatives, and projects funded by the National Natural Science Foundation of China, providing data management services for numerous clinical studies. “My market experience over these years has further validated my perspective,” said Zhao Guang. “Although some enterprises had already entered the domestic EDC market, most only served pharmaceutical companies and CROs, neglecting the needs of clinical investigators. This presents our opportunity.”

A hospital's ICU is using the Yirui EDC system.

“From a research-oriented system design perspective, we prefer having professional clinical researchers communicate with users,” said Zhao Guang. Most members of the Siluxin team come from Tongji Medical College of Huazhong University of Science and Technology, with equal representation from the technical and clinical teams. By liaising with hospitals, developers gain insight into specific needs for data analysis in clinical trials, then design structured data entry methods, follow-up management, and project progress tracking. Finally, AI algorithms are designed to enhance database quality by removing unreasonable or extreme data values, ensuring data integrity.

YiRueStructured Data Entry in EDC Systems

Regarding other core members of Siluxin, Chief Technology Officer He Yiyuan graduated from Huazhong University of Science and Technology. He began learning programming in high school, developed a teaching system for his college during his undergraduate studies, and previously served as the Technical Director of the MEB team. Co-founder Luo Kairui holds a Ph.D. in Finance from Xiamen University. He formerly worked at Tasly, where he became the youngest Regional Manager and received the “President’s Special Award,” and also served as Deputy General Manager of Shihuida Pharmaceutical.

The Yirui EDC Cloud Platform by Siluxin primarily features four major application scenarios: integration with hospitals’ official HMS systems to establish departmental databases; a cohort and epidemiological survey system adapted for iPad, used for questionnaire surveys and data quality control; a multi-center clinical database for the management and quality control of multi-center clinical studies; and a drug clinical trial data management system compliant with GCP regulations and CDISC data standards, designed for intelligent data verification.

“We extend the application of EDC systems to clinical research in hospitals through a more convenient, efficient, and cost-effective approach. Moreover, our system offers personalized interfaces tailored to specific clinical research needs,” revealed Zhao Guang. For tertiary Grade-A hospitals and small CROs, traditional EDC systems on the market can cost as much as RMB 1 million, whereas Siluxin’s Yirui EDC system is priced at approximately RMB 100,000–300,000. A single system can simultaneously manage multiple projects, significantly reducing R&D costs for hospitals and small CROs. To date, Siluxin has partnered with over 300 clients, including Tongji Hospital, the Chinese Center for Disease Control and Prevention, and Peking University People’s Hospital, with more than 70 contracted projects and a customer repurchase rate as high as 40%.

Selected Partner Clients of Siluxin

“For the past four years, our client base has grown primarily through word-of-mouth, with minimal promotional efforts,” said Zhao Guang proudly. Looking ahead, Siluxin will delve deeper into customer value within the EDC niche segment targeting hospitals and small-to-medium-sized CROs, by conducting in-depth clinical data analysis and mining. “From the initial design of clinical studies, to the establishment of project-specific databases, and finally to subsequent data analysis, we aim to support clients in completing clinical research projects more efficiently across the entire clinical research industry chain.”

According to a reporter from VCBeat New Medicine, Siluxin will release 15% of its shares in search of a new round of financing amounting to RMB 10 million. The funds will be used for product research and development upgrades as well as market promotion.