Committed to Excellence, Competing Globally: MDCE CRO 2025 Annual Achievements Report

In 2025, the global expansion of Chinese pharmaceutical and medical device companies is undergoing a paradigm shift from “scale-driven growth” to “value-based competition.” MDCE CRO believes that going global is no longer a simple geographic replication, but rather a profound restructuring centered on “regulatory sovereignty, academic standing, and commercial respect.”

Over the past year, amidst a complex international landscape, MDCE CRO has turned challenges into opportunities, establishing a presence simultaneously in R&D hubs across Europe and the United States as well as in emerging high-potential markets. We have achieved efficient operations30+ Overseas Projects, spanning18 countries and regions, won with outstanding delivery capabilities67% Annual Customer Repurchase Rate, facilitating the successful overseas launch of innovative Chinese pharmaceuticals and medical devices. We are not merely executors of clinical studies, but co-creation partners in the global journey of Chinese enterprises. MDCE CRO is committed to transforming top-tier global clinical resources into robust support for Chinese innovations going global, ensuring that every technological innovation earns its rightful commercial position and industry respect in the international market.

In 2025, MDCE CRO’s global operational network continued to expand, with steadily enhanced delivery capabilities. Its clinical business footprint still spanned the four major regions of Europe, North America, Asia, and Australia.Covering 14 countries，Links to more than 30 overseas clinical research centers.The project spans a wide range of therapeutic areas, covering key sectors such as cardiovascular disease, neurosurgery, endocrinology, and dermatology, providing in-depth professional support.

During the full-year operation of overseas clinical projects,Projects in Europe and the United States account for 89%, and clinical research centers in Europe and the United States account for 86%., forming a regional delivery network centered on the R&D hubs in Europe and America, thereby achieving precise allocation of global superior resources.

In terms of subject recruitment and enrollment, the MDCE CRO clinical team demonstrated efficient global execution capabilities. A cumulative total of subjects were screened throughout the yearOver 1,000 Cases, achieving extensive reach among the global target population and further validating MDCE CRO's full-stack service capabilities across multiple indications.

Meanwhile, we continue to push the boundaries of efficiency, successfully delivering high-quality clinical projects under stringent conditions on multiple occasions. In the European market, we have achieved rapid response with “initiation upon signing.” Faced with the dual challenges of a cross-border supply chain and urgent timelines, our team has onlyFor 2 monthscompleted.Nearly 100 Subjects Fully Enrolled, demonstrating MDCE CRO's efficient delivery capabilities in overseas clinical operations through tangible results, and further reflecting our commitment to helping Chinese enterprises rapidly build competitive barriers in the heart of Europe and secure a first-mover advantage in commercialization.

While strengthening its operational foundation, MDCE CRO’s regulatory consulting business deeply focused on high-barrier market access areas in 2025, with newly signed contracts throughout the year20+ Overseas Registration and Regulatory Consulting Projects, with operational coverage spanning11 Countries/Regions, among whichProjects in Europe and the United States accounted for 46%.

Leveraging MDCE CRO’s specialized service for FDA Breakthrough Device Designation (BDD), we completed within the year4 FDA BDD Itemstop-level strategic design, covering cutting-edge fields such as surgical robotics, structural heart disease, and neurointerventional procedures. Meanwhile, in the European and Asian markets, we continue to unlock our delivery potential. With steady progress inEuropean Registration and High-Difficulty CER ProjectsAt the time of delivery, we provide supportMultiple Products Rapidly Approved in the Southeast Asian Market, successfully establishing a full-loop closed circuit from top-level strategy to compliant market access in emerging markets.

Facing the challenges of high-difficulty projects, MDCE CRO continues to break through. We have assisted clients with Class III implantable medical devices in successfully obtainingEthics Committee (EC) Approval for the First-in-Human (FIH) Clinical Study. Facing the market access challenges for Class D high-risk crystal implant products, the teamAchieved Rapid Approval in Just 3 Months. MDCE CRO has demonstrated excellent compliance quality and operational efficiency, safeguarding the global validation of China’s innovative medical devices.

At the end of 2025, MDCE CRO released its self-developed productChina's First AI Tool for CER (Clinical Evaluation Report), officially ushering in the company’s “AI-native” era. The CER AI tool establishes a complete intelligent workflow spanning from automated literature retrieval and in-depth analytical scoring to report generation.Compress the traditional 80-hour turnaround time to under one hour, achieving a 97% labor substitution rate“Zero Threshold”Getting Started with"Minute-level"Delivery. We simultaneously introduce“Human-in-the-Loop” Human-Machine Collaboration Mechanism, supports natural language-based custom standards and end-to-end data traceability, thoroughly redefining the efficiency boundaries of clinical evaluation while ensuring medical rigor.

In the future, MDCE CRO will leverage CER AI as a starting point to comprehensively drive the intelligent restructuring of business processes, deeply integrating AI technology into all scenarios of regulatory submission, compliance, and clinical operations, thereby continuously leading the digital and intelligent transformation of medical device lifecycle management.

Behind globalized delivery lies strong support from core resources. In 2025, MDCE CROThe global network of clinical experts has undergone a strategic upgrade, achieving robust growth of 32%.and withOver 90 Internationally Renowned Principal InvestigatorsEstablished in-depth scientific research collaboration. We have successfully constructedEurope (61%), North America (25%), Asia-Pacific (14%)a globalized resource landscape that deeply covers core, high-barrier sectors such as cardiology, ophthalmology, and gastroenterology & hepatology, forming a global scientific collaboration network that spans time zones and integrates multiple disciplines.

Meanwhile, this year's HaiThe number of overseas partner medical institutions has increased by more than 30% in scale., further expanding the company's business boundaries. The newly added resources are primarily focused onEurope (62%) and Asia-Pacific (33%), encompassing premium resources in key therapeutic areas such as cardiovascular medicine, dermatology, and surgery. This highly interconnected international clinical trial network further enhances MDCE CRO’s comprehensive global R&D footprint, providing robust support for Chinese enterprises to access cutting-edge scientific insights, accelerate the implementation of multi-center projects, and facilitate overseas market access and commercialization of their products.

In 2025, the overseas team of MDCE CRO steadily expanded. Throughout the yearAdded Nearly 20 Overseas Core Experts. The newly established teams cover key markets including Europe, North America, South America, and Southeast Asia, among which,Nearly 65% of New Hires Are in Europe, the Core Delivery Region. New positions comprehensively cover core functions such as Senior Project Manager, Senior Clinical Research Associate, and Safety Specialist.

Add Team MembersAverage Industry Experience: 15+ Years, over 80% hold a master’s degree or higher in medicine, and most possessJohnson & Johnson, AstraZeneca, IQVIA, and other leading international pharmaceutical companies and CROsprofessional background. Leveraging profound compliance expertise, an international professional background, and extensive practical experience, he has significantly strengthened MDCE CRO’s technical responsiveness in complex regulatory environments, building a solid professional foundation for the efficient delivery and quality control of Chinese innovative drugs and medical devices going global.

In 2026, MDCE CRO will continue to serve as a co-creator in the globalization of Chinese healthcare enterprises, fully building a core engine that connects “Chinese Innovation” with “Global Excellence Standards.” Leveraging top-tier global expert teams and tailored overseas expansion strategies, we will assist companies in identifying the optimal pathways for international market entry amidst complex regulatory environments. Furthermore, by enhancing efficiency through intelligent solutions, we will help Chinese innovative drugs and medical devices establish overseas channels with greater cost competitiveness and delivery certainty, ensuring that Chinese innovations benefit people worldwide!

MDCE CRO is a medical device research and development outsourcing company centered on global clinical trials. Leveraging Harvard University’s global medical research resources and academic influence, MDCE CRO has established a comprehensive overseas service value chain to provide customized global market entry solutions for Chinese medical device enterprises. Its services encompass overseas clinical development strategy and design, management and operation of overseas clinical trials, overseas product registration, and international commercialization planning. Since its inception, MDCE CRO has successfully facilitated the overseas launch of more than 80 medical device and biopharmaceutical projects, generating cumulative overseas profits exceeding RMB 20 billion for its clients. Currently, MDCE CRO employs an in-house overseas clinical trial team of over 100 professionals, collaborates with more than 2,000 experts, and has partnered with over 100 renowned overseas hospitals, covering regions including the European Union, North America, Australia and New Zealand, Southeast Asia, Japan and South Korea, the Middle East, and Africa.

For inquiries regarding overseas clinical and regulatory affairs, please scan the QR code to submit your information, or contact us via the following methods:

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