YiLinCloud eTMF System Powers Yuanxin Tech's International Multicenter Clinical Trial

Yi Lin Yun (Shenzhen) Technology Co., Ltd. (hereinafter referred to as “Yi Lin Yun”) and Yuanxin Technology (Shenzhen) Co., Ltd. (hereinafter referred to as “Yuanxin Technology”) recently announced that they have further deepened their collaboration, with Yuanxin Technology adopting Yi Lin Yun’s eTMF (electronic Trial Master File) solution for its international multicenter clinical trial project on bioresorbable stents for the popliteal artery. Leveraging its information management platform and extensive experience, Yi Lin Yun supports Yuanxin Technology’s global business development needs, helping it become a leading global cardiovascular medical device enterprise.

Yuanxin Technology, spun off from Lifetech Scientific, specializes in the research and development of iron-based bioresorbable materials and devices. Currently, clinical trials for Yuanxin Technology’s below-the-knee artery bioresorbable stent are being conducted at 14 hospitals across Italy, Germany, France, Belgium, Greece, and Austria. The Yilin Cloud eTMF system provides robust support for the collection and management of trial documentation in this study.

For Trial Master Files (TMF), which can contain over 100,000 documents, approximately 35% of clinical trial inspections are delayed due to incomplete or hard-to-review TMFs. Yilin Cloud eTMF is a professional-grade electronic document management system developed based on actual clinical research workflows, primarily used for storing, managing, and tracking clinical trial documents. It accurately and comprehensively reproduces evidence of actions taken and decisions made during the clinical trial execution process. By leveraging milestone-driven document collection and automatic document naming features, it ensures the integrity, compliance, timeliness, and traceability of trial documents, thereby improving the quality and efficiency of document collection.

Furthermore, its multilingual environment supports international clinical trials by enabling flexible configuration based on trial types and regulatory requirements across different countries and regions. This empowers domestic innovative pharmaceutical companies in their global expansion efforts by delivering professional services aligned with international standards.

Ms. Xia Ying, Director of Clinical Operations at Yuanxin Technology, stated: “Yuanxin Technology is committed to its mission of providing safe and innovative cardiovascular medical devices to physicians and patients worldwide, striving to become a global leader in the cardiovascular field. Currently, the world’s only iron-based bioresorbable vascular scaffold has initiated clinical implantation in the United States, Europe, Southeast Asia, and China. We attach great importance to this clinical study and believe that information technology can bring new momentum and transformation to the clinical research and development of medical devices. By choosing to collaborate with Yilinyun again, we hope to leverage Yilinyun’s advanced technology platform to help Yuanxin Technology manage clinical trial documentation more effectively and in a more standardized manner, thereby enhancing clinical operational efficiency.”

Dr. Qin Long, CEO of Yilinyun, expressed his gratitude for the support and trust from Yuanxin Technology: “Yuanxin Technology and Yilinyun have always maintained a close and collaborative partnership. We are delighted to explore new areas of cooperation with Yuanxin Technology, which serves as a testament to the recognition of Yilinyun’s products and services. Product internationalization has long been an unwavering strategic priority for Yilinyun. Our eTMF system not only serves domestic pharmaceutical companies but also boasts a broad user base in Europe and the United States, covering international multi-center trials for innovative drug developers as well as foreign CROs, thereby accumulating extensive experience. Moving forward, we will continue to leverage our strengths to build products with international competitiveness, better supporting Chinese enterprises in clinical development and their global expansion strategies, and driving the high-quality development of innovation in China’s pharmaceutical and medical device industries!”

Yi Lin Yun Technology is a healthcare and life sciences enterprise based in China and serving the global market. Guided by its mission to “deliver effective treatments to patients through technological innovation,” the company is driven by science and medicine. By integrating digital technologies with life science data, it has built a comprehensive cloud platform for digital clinical trials and provides technical solutions for clinical endpoint assessment. These offerings help pharmaceutical companies and research institutions both in China and abroad improve R&D efficiency and accelerate the market approval of drugs and medical devices, ultimately benefiting countless patients.