LinYanTong Files IPO Prospectus: Accelerating Efficient Clinical Trials Through Private-Deployed Digital Solutions

Long development timelines, substantial capital investment, and broad personnel involvement remain persistent pain points in new drug development.

In recent years, AI technology has become increasingly active in the theoretical research and drug discovery phases of new drug development, significantly shortening the preclinical research timeline. Although companies such as UNLEARN have already applied AI technology to clinical trials worldwide, the overall level of digitalization in this phase remains relatively low.

VCBeat recently interviewed Linyantong (Tianjin) Technology Co., Ltd., a provider of clinical digital service solutions.(hereinafter referred to as "Linyantong"), itsFounder: Duan ZhongchengStated in the interview: “Currently, the industry’s progress in digitalization is relatively slow. This is because every industry undergoes a progression from quantity to quality and then to efficiency, and the clinical trial industry is currently still in the ‘quality’ development stage.”Once the number of research centers expands to 2,000 or more, we believe that solutions for digital clinical trials will gradually shift toward pursuing efficiency, and effective data utilization is expected to be achieved.”

Linyantong, staying true to its original mission of advancing digital clinical research, has independently developed:Linyantong Intelligent Monitoring System for Clinical Trials has now obtained the Level 3 Classified Protection Certification from the Ministry of Public Security.

This system is an intelligent, collaborative, efficient, and real-time product for the clinical research services sector.Project-centric, linking every individual and organization involved in the project through data exchange and process collaboration in clinical research,Enable real-time sharing of project process information to eliminate information asymmetry and enhance the efficiency of data collection and processing.。

TT Capture is a new generation of intelligent electronic data capture system for clinical research, independently developed by Linyantong over eight years.The system complies with FDA 21 CFR Part 11, CDISC, and GAMP5 standards, achieving a 100% pass rate in regulatory submission audits. It has been integrated into multiple products that have received NDA approval and been launched on the market.

In addition to traditional data collection methods such as manual entry and OCR recognition, the system has completed simulated data integration and synchronization testing with the data warehouses of multiple hospitals. It is capable of running automated online verification procedures, significantly improving data collection efficiency and data quality, thereby achieving true data interoperability in clinical research.

TT CTMS is a clinical trial project management system developed by Linyantong, centered on personnel and project management, cost-oriented, and covering the entire project lifecycle.. This system complies with the quality management standards and regulations for clinical trials of drugs, medical devices, vaccines, and other products as stipulated by the NMPA, FDA, and the European Union, enabling end-to-end management of project initiation, planning, execution, monitoring, and closeout.

The system enables comprehensive management of resources, scope, schedule, and cost throughout the entire project lifecycle, leveraging intelligent alerts for schedule and cost variances. It facilitates real-time sharing with full information transparency, thoroughly resolving information silo issues. The system supports private deployment, allowing users to customize databases, file templates, and approval workflows according to project requirements, while ensuring the security of critical data such as project plans, operational metrics, and labor costs.

TTDriver is a dashboard tool independently developed by Linyantong for sponsors/CROs, based on clinical research project management., real-time monitoring of company project budgets, labor costs, effective output value of project execution, achievement of key project milestones, and performance evaluation data for R&D teams. A digital solution that truly realizes the digital management and control of clinical research in accordance with the fundamental logic of personnel, finance, and operations, effectively supporting decision-making in clinical research.

This management tool enables data interoperability with the TT Capture system., to minimize data distortion during the reporting process, while also supporting customized development and private deployment. By linking corporate financial bookkeeping with project budgets, payment collections, reimbursement, and other information, it provides real-time insights into R&D investment, labor costs, and other metrics for effective project financial management. It can also automatically conduct performance evaluations for R&D team members, breaking down labor costs to individual task clock-ins to reflect work efficiency and assist in personnel decision-making.

TT Pool is a clinical research data exchange system independently developed by Linyantong, designed to meet the needs of de-identification and privacy protection for clinical research data and aligned with CDISC standards.. This system is designed to facilitate scheduled data exchange of subject data across the “Hospital–TT Pool–EDC” workflow. By enabling rapid synchronization of patient data, it fundamentally addresses the challenges associated with traditional paper-based entry into EDC systems, such as cumbersome documentation, high error rates, poor data quality, and difficulties in archiving, thereby effectively reducing costs. Project testing has demonstrated that it can save more than 50% of the labor costs associated with clinical research.

As a data interaction system, TT Pool provides data de-identification and selective value extraction capabilities to effectively protect subject privacy. It also encrypts data and performs scheduled synchronization to prevent data leaks. Combined with private deployment features, it addresses data security concerns for both internal and external stakeholders.

TT SIMS is a clinical research institution management system independently developed by Linyantong, based on multi-party collaboration (institutions and sponsors).. It provides perspectives for multi-hospital management and institutional management, thereby addressing the needs of both hospital group administration and oversight by superior health supervision authorities. Guided by a single-view display of aggregated multi-project data, it establishes standardized operational procedures and tasks for all stakeholders across the preparation, execution, and closure phases of clinical research projects.

This management system supports on-premises deployment and data interoperability with hospital information systems, enabling clinical research institutions to effectively manage projects through information technology and enhance operational capabilities. Furthermore, when integrated with the TT Pool, it enables direct data flow from clinical studies to the Electronic Data Capture (EDC) system, eliminating manual entry and significantly improving trial quality and efficiency.

TT Task is an open, one-stop medical task posting platform independently developed by Linyantong.. By leveraging an internet-based crowdsourcing collaboration model and adhering to the service philosophy of sharing, professionalism, and efficiency, this approach addresses the characteristics of numerous clinical trial centers and dispersed personnel. It provides solution providers in the pharmaceutical R&D and promotion industry with comprehensive services including clinical research, academic promotion, project surveys, and flexible staffing.

The platform supports operation in both PC and mobile modes, freeing users from service scenario constraints. With simple operations, users can quickly locate and match personnel, advance service completion according to system-preset workflows, and reduce ineffective communication. Additionally, the platform integrates with tax regulatory systems to guide tax compliance and effectively mitigate tax risks.

Within the Linyantong Intelligent Clinical Trial Monitoring System, four products—TT Capture, TT CTMS, TT SIMS, and TT Pool—can be deployed independently. The integrated system combines offline SMO (Site Management Organization) service models with the application of new clinical research technologies and organizational operational capabilities to enhance the efficiency of clinical R&D.

In consideration of the requirements for industry compliance and data security, as well as the preference for private deployment by hospitals, CROs, and sponsors, all Linyantong system software can be installed and operated on local servers.

Rapid deployment is achieved simply by executing the installation package, enabling personalized customization of various functions. It features low hardware requirements, simplified operations and maintenance, and supports firewall-based intranet isolation. Data and file privatization empowers users with full control over their data and access permissions, enhancing security. The solution offers strong scalability and facilitates data interoperability, allowing for rapid integration with existing systems and other designated platforms.

Compared with large CROs’ self-developed digital clinical trial management systems, procuring a system like Linyantong that supports private deployment not only eliminates the financial and team costs associated with system development, ongoing maintenance, and continuous iteration, but also enables the rapid acquisition of a systematic, comprehensive, and compliant management platform, thereby facilitating the prompt initiation of relevant clinical trials.

For the industry as a whole,Only by first applying digital products to enterprise digital operations can the digital ecosystem of the entire industry be realized.. Private deployment has significantly enhanced the feasibility of digital operations for enterprises. Comprehensive private deployment solutions, such as the Linyantong Intelligent Clinical Trial Monitoring System, have also greatly improved the quality and efficiency of companies involved in clinical trials.

“The development of China’s pharmaceutical industry will inevitably drive the growth of clinical trials. As clinical research centers expand and mature, ‘providing better services’ will undoubtedly become a key objective pursued within the industry amid market competition.”Duan ZhongchengIt was stated that the enthusiasm of clinical research centers will increase with the development of the clinical trial management industry, and this pace of development will only continue to accelerate.

Data from Boston Consulting Group shows that, under the impact of the pandemic, corporate investment in digitalization rose significantly from 23% to 40% within one year, and is expected to remain at a high level for the long term even after the pandemic ends.

Amid the growing corporate pursuit of digitalization and the favorable development of the pharmaceutical industry,The increasing time required by clinical research centers also presents a golden opportunity for digital clinical research service solution providers to deepen their market understanding and refine their products.。

Seizing the opportunity to enhance clinical trial quality, we aim to boost recognition of digitalization in clinical trial management. Leveraging improved efficiency as a strategic advantage, we integrate intelligent technologies—such as risk prediction, behavioral guidance, and data exchange—to promote the widespread adoption of digital solutions in clinical trials. This has always been the development goal of Linyantong, and it is also a shared pursuit across the industry!