Sadeson Files IPO Prospectus: Driving Quality and Efficiency in Clinical Trials through WeTrial Digital Platform

“2010 marked a turning point for China’s CRO industry, ushering in a new era.” Reflecting on his decision nine years ago, Wang Jinhai feels deeply fortunate. From the implementation of the new regulations in 2007 until 2010, the three-year validity period for clinical trial approvals had just expired. This meant that all clinical trials initiated from 2010 onward were conducted under the stricter and more standardized requirements imposed by the new regulations. It was against this backdrop that Wang Jinhai, together with five founding shareholders, established Beijing CTSmed Co., Ltd. in Beijing in November 2010.

Previously, Wang Jinhai, who has a background in clinical medicine, successively held management positions in the clinical research departments of pharmaceutical companies and CROs. While marveling at the rapid development of domestic CROs, Wang also identified flaws in the industry’s growth: most CROs have expanded in an unregulated manner, with a notable lack of innovative companies that adhere to standardized system-building practices.

At that time, following the promulgation of the new Measures for the Administration of Drug Registration by the former State Food and Drug Administration in 2007, the Ministry of Health issued the Good Manufacturing Practice for Drugs (2010 Revision) in October 2010. “I felt then that this was an opportunity, as the entire CRO market would enter a more standardized and orderly growth environment,” said Wang Jinhai.

Since its inception, Beijing CTSmed Co., Ltd. has primarily provided clinical trial registration and research services for Phase III drugs to pharmaceutical enterprises. In 2013, its subsidiary, Dinghui Sichuang, was established, specializing in third-party quality management services for clinical trials in pharmaceutical product development. In 2014, the company was recognized as a National High-Tech Enterprise, listed on the New Third Board, and achieved annual sales exceeding RMB 100 million. In 2015, the company’s CRO business continued to expand, and it completed its Series A financing round. Over the five years since its establishment, the company’s performance has grown at an annual rate of nearly 100%.

“As business volume has increased year by year, the difficulty of clinical trial management has gradually intensified. However, under the traditional clinical trial management model, information exchange among sponsors, investigators (including institutional administrators), CROs, and regulatory authorities is often delayed, creating information silos across all stages. Consequently, clinical trial management has been limited to retrospective oversight, failing to identify issues in a timely manner. ‘In 2014, with mobile internet technology being rapidly adopted across various industries, we decided to independently develop WeTrial, an intelligent, integrated cloud-based platform for clinical trials. This was the first clinical trial management system in China—and indeed globally—designed entirely based on cloud computing principles,’ stated Wang Jinhai. WeTrial aims to break down information silos among stakeholders involved in clinical trials, improve management efficiency, and better ensure the quality of clinical trial execution.”

In 2017, CTSmed’s WeTrial system was built and fully put into use, and its subsidiary Hunan Microtrial Cloud was established, focusing on informatization of clinical research. “WeTrial can significantly improve the quality and efficiency of clinical trial projects, laying the foundation for the company’s subsequent business transformation,” said Wang Jinhai. He believed that following the reform of national drug registration classification—reclassifying the former Category 3 new drugs (drugs already marketed abroad but not yet in China) as new Category 3 generic drugs (generic versions of original innovative drugs already marketed abroad but not yet in China)—the policy orientation led to a surge in applications for domestically produced innovative drugs in 2017, bringing broad market prospects to the CRO industry driven by drug R&D.

Against the backdrop of favorable policies and a vast market, the establishment of WeTrial is certainly the icing on the cake. In August 2017, Beijing CTSmed Co., Ltd. completed its Series B financing. Since 2017, the company has begun undertaking clinical projects for innovative drugs. Over the following two to three years, it gradually formed four core business segments: clinical trial services for innovative drugs, clinical trial services for high-end generic drugs, integrated IT solutions for clinical trial management, and independent third-party auditing and quality management for clinical research. To date, the company has undertaken nearly 10 innovative drug projects.

Regarding the company’s robust development, Wang Jinhai told VCBeat that it largely depends on the structure of its core team. “We are the first contract research organization (CRO) in China founded through a partnership model.” Since its inception, the company’s founding shareholders and core team have remained relatively stable. Founder and Chairman Wang Jinhai has extensive clinical research experience in the fields of oncology, neurological disorders, and cardiovascular diseases. He also serves as a principal investigator for drug clinical trials and stands as an executive director of the Zhongguancun Jiutai Drug Clinical Trial Technology Innovation Alliance. Chief Scientific Officer Liu Chaoyi brings over 20 years of experience in clinical strategy planning for anti-tumor and biological innovative drugs, having successfully completed multiple preclinical development and clinical new drug research projects for innovative pharmaceuticals. Chief Operating Officer Xu Qianyi possesses more than 15 years of experience in corporate management, organizational development, and human resources management.

In addition, other core members of the company are each responsible for their respective core business modules. “We also actively and openly recruit outstanding professional talent,” said Wang Jinhai.

“The WeTrial platform is designed based on a cloud architecture, with project execution and management at its core. This represents a product form entirely different from traditional software information systems for organizational management, with a management system that covers the entire lifecycle of clinical trials,” explained Wang Jinhai. WeTrial is an intelligent, integrated cloud platform for clinical trials, independently developed by Beijing CTSmed Co., Ltd. It serves as a comprehensive clinical trial management solution, integrating PV (Pharmacovigilance), CTMS+eTMF (Clinical Trial Management System + electronic Trial Master File), SIS+ECS (Site Information System + Ethics Committee System), EDC+IWRS (Electronic Data Capture + Interactive Web Response System), and eCTD (electronic Common Technical Document).

Clinical trial management often involves multiple stakeholders. The high costs, uncontrollable quality, and low efficiency of clinical trials are largely attributed to the multiplicity of data sources, prolonged trial durations, low rates of information sharing, and inefficient cross-organizational task collaboration.

By integrating multiple systems into a unified platform, WeTrial serves as a nexus connecting sponsors, CROs, clinical trial sites, and regulatory authorities. Built on a cloud-based product architecture, the WeTrial platform enables complete data sharing. “When the product reaches its idealized stage, theoretically, any data point in clinical research can be entered once and shared in real time across the platform,” stated Wang Jinhai.

Furthermore, the WeTrial platform enables cross-regional and cross-organizational task collaboration for the same project. This collaborative approach transforms traditional retrospective reporting-based clinical trial management into a process-oriented dynamic management model, thereby facilitating timely or even real-time issue detection, solution proposal, and risk alerting. The WeTrial platform adopts a Software-as-a-Service (SaaS) delivery model, fully supporting mobile access via WeChat and dedicated apps, allowing users to select functional modules as needed.

WeTrial Integrated Cloud Platform for Clinical Trials

Currently, CTSmed’s WeTrial system serves more than 30 corporate clients and supports the management of over 300 clinical trial projects. Meanwhile, the company has more than 80 clinical trial institution clients. “WeTrial is currently the market-leading clinical trial institution management system in terms of market share, and it is the only system comprehensively used across the entire workflow from project initiation to study closure,” said Wang Jinhai.

Regarding future development, Wang Jinhai stated, “Over the next three years, we will leverage WeTrial to deepen our clinical trial service capabilities centered on innovative drugs, connect pharmaceutical companies with clinical trial centers, and empower clinical research on innovative drugs.”

To ensure more robust development, Beijing CTSmed Co.,Ltd. is also preparing for a new round of financing, aiming to raise RMB 100 million for the continued construction and operation of the WeTrial platform, business expansion, marketing promotion, and recruitment of core talent.