MDCE CRO

2025 Annual Report

A New Global Landscape: From ScaleExpansion to Value Cultivation

In 2025, the global expansion ofpharmaceutical and medical device companies underwent a paradigm shift from"scale expansion" to "value competition." MDCE CRO believesthat going overseas is no longer a simple geographic transition, but a deeprestructuring of "compliance sovereignty, academic standing, andcommercial respect."

Over the past year, MDCE CRO transformedchallenges into opportunities, establishing strongholds in both high-endEuropean/American R&D hubs and emerging potential markets. We efficientlyoperated 30+ overseas projects across 18 countries and regions.With exceptional delivery capabilities, we achieved a 67% annual customerretention rate, assisting Chinese innovative MedTech & BioTechcompanies in successfully launching abroad. We are not merely executors ofclinical research; we are co-creation partners in the globalization journey ofChinese enterprises. MDCE CRO is committed to transforming top-tier globalclinical resources into a solid foundation for Chinese innovation, ensuringevery technological breakthrough earns its rightful commercial position andindustry respect on the international stage.

2025 Key Performance Indicators：

• Global Projects: 30+ global projects operated; business successfully launched in 18 countries/regions.
• Customer Trust: 67% annual customer retention rate.
• Clinical Footprint: Overseas clinical projects covered 14 countries with 30+ clinical research centers; European and American projects accounted for 89%.
• Regulatory Access: Overseas registration projects covered 11 countries/regions; European and American projects accounted for 46%.
• Resource Network: 30% increase in top-tier partner hospitals globally; 32% expansion of authoritative international Principal Investigator (PI) resources.
• AI-Native: Released China's first CER AI tool, compressing an 80-hour work cycle to minutes—a revolution in efficiency.
  

Excellence in Clinical Trial Delivery

In 2025, MDCE CRO’s global operationsnetwork continued to broaden, and our delivery capabilities improved steadily.Our clinical business map spans 14 countries across Europe, America, Asia, andAustralia, linking over 30 overseas clinical research centers. The projectscover critical therapeutic areas such as cardiovascular, neurosurgery,endocrinology, and dermatology, providing deep professional support.
Within our annual overseas clinical operations, projects in Europe andAmerica accounted for 89% of the total, with 86% of clinical research centerslocated in these regions, forming a delivery network centered on high-endR&D hubs for the precise allocation of global resources.Our teamdemonstrated high-efficiency execution by screening over 1,000 subjectsglobally, verifying our full-stack service capabilities across multipleindications.
Notably, in the European market, we achieved a "Start-up uponSigning" response. Despite the double challenge of cross-border supplychains and urgent timelines, the team completed full enrollment for nearly100 subjects in just 2 months, showcasing our efficiency and commitment tohelping Chinese enterprises build competitive barriers in Europe.

Breakthroughs in Regulatory Access

While consolidating our operationalfoundation, our registration and consulting business focused on high-barrierentry sectors in 2025. We signed more than 20 new overseas registration andregulatory consulting projects across 11 countries and regions, with 46%focused on European and American markets.
Relying on our specialized FDA Breakthrough Device Designation (BDD) services, wecompleted top-level strategy designs for 4 FDA BDDs in fields such assurgical robotics, structural heart disease, and neurointervention.Simultaneously, we facilitated rapid approvals for multiple products inSoutheast Asian markets while progressing with high-difficulty Europeanregistration and CER projects. We successfully assisted a Class IIIimplantable medical device client in obtaining Ethics Committee (EC) approvalfor a First-in-Human (FIH) study. For a Class D high-risk lens implantproduct, the team secured rapid approval in only 3 months, demonstratingsuperior compliance quality and operational efficiency.

Productivity Reimagined via AI-NativeSolutions

The launch of our self-developed Chinafirst CER AI tool at the end of 2025 officially marked the beginning of our"AI-native" era. This tool automates theentire chain from literature retrieval and depth analysis to report generation,reducing the traditional 80-hour work cycle to under 1 hour. By achieving a97% manual labor replacement rate, we have achieved "zero-threshold"usage and "minute-level" delivery. We have also introduced a"Human-in-the-loop" collaborative mechanism that supports naturallanguage customization and full data traceability to ensure medical rigor whileredefining the efficiency boundaries of clinical evaluation. In the future,MDCE CRO will use CER AI as a starting point to comprehensively promote theintelligent reconstruction of business workflows, deeply integrating AI intoregistration filing, regulatory compliance, and clinical operations.

Scientific Synergy of Global ClinicalResources

Our global expert network achievedstrategic growth of 32% in 2025, with deepscientific collaborations established with over 90 international PIs. Wehave constructed a global resource map distributed across Europe (61%),North America (25%), and the Asia-Pacific (14%), covering high-barriersectors like cardiology, ophthalmology, gastroenterology, and hepatology.Additionally, the number of overseas partner medical institutions increasedby over 30%, primarily in Europe (62%) and the Asia-Pacific (33%).This interconnected international network provides a solid foundation forChinese enterprises to access cutting-edge research, accelerate multi-centerproject implementation, and push forward overseas market access andcommercialization.

Steady Expansion of Overseas Talent

MDCE CRO's overseas team scale grewsteadily in 2025, with nearly 20 core experts added across Europe, NorthAmerica, South America, and Southeast Asia. Europe, as our core deliveryregion, accounted for nearly 65% of these new hires.These positions cover essential functions such as Senior Project Manager,Senior Clinical Research Associate (SCRA), and Safety Specialist. Our newteam members bring an average of more than 15 years of industry experience,with over 80% holding a Master's degree or higher in medicine. Many possessprofessional backgrounds from top-tier international firms like Johnson &Johnson, AstraZeneca, and IQVIA. Their deep compliance literacy andinternational expertise significantly strengthen our ability to handle complexregulatory environments and ensure high-quality delivery.

2026 Outlook: Defining New Standards forGlobal Service

In 2026, MDCE CRO will continue to serve as aco-creator for global medical enterprises, building the core engine thatconnects frontier innovation with "Global Standards ofExcellence." We will utilize our global expert teams and tailoredstrategies to help companies lock in the optimal path for overseas expansionwithin complex regulatory environments. By leveraging intelligent tools toincrease efficiency and delivery certainty, we aim to help Chinese innovativepharmaceutical and medical device products build competitive advantages andbenefit the world.