MDCE CRO 2025 Annual Report

A New Global Landscape: From Scale Expansion to Value Cultivation

In 2025, the global expansion of pharmaceutical and medical device companies underwent a paradigm shift from "scale expansion" to "value competition." MDCE CRO believes that going overseas is no longer a simple geographic transition, but a deep restructuring of "compliance sovereignty, academic standing, and commercial respect."

Over the past year, MDCE CRO transformed challenges into opportunities, establishing strongholds in both high-end European/American R&D hubs and emerging potential markets.  We efficiently operated 30+ overseas projects across 18 countries and regions. With exceptional delivery capabilities, we achieved a 67% annual customer retention rate, assisting Chinese innovative MedTech & BioTech companies in successfully launching abroad. We are not merely executors of clinical research; we are co-creation partners in the globalization journey of Chinese enterprises. MDCE CRO is committed to transforming top-tier global clinical resources into a solid foundation for Chinese innovation, ensuring every technological breakthrough earns its rightful commercial position and industry respect on the international stage.  

2025 Key Performance Indicators:

Excellence in Clinical Trial Delivery

In 2025, MDCE CRO’s global operations network continued to broaden, and our delivery capabilities improved steadily. Our clinical business map spans 14 countries across Europe, America, Asia, and Australia, linking over 30 overseas clinical research centers. The projects cover critical therapeutic areas such as cardiovascular, neurosurgery, endocrinology, and dermatology, providing deep professional support.

Within our annual overseas clinical operations, projects in Europe and America accounted for 89% of the total, with 86% of clinical research centers located in these regions, forming a delivery network centered on high-end R&D hubs for the precise allocation of global resources. Our team demonstrated high-efficiency execution by screening over 1,000 subjects globally, verifying our full-stack service capabilities across multiple indications.

Notably, in the European market, we achieved a "Start-up upon Signing" response. Despite the double challenge of cross-border supply chains and urgent timelines, the team completed full enrollment for nearly 100 subjects in just 2 months, showcasing our efficiency and commitment to helping Chinese enterprises build competitive barriers in Europe.

Breakthroughs in Regulatory Access

While consolidating our operational foundation, our registration and consulting business focused on high-barrier entry sectors in 2025. We signed more than 20 new overseas registration and regulatory 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, we completed top-level strategy designs for 4 FDA BDDs in fields such as surgical robotics, structural heart disease, and neuro intervention. Simultaneously, we facilitated rapid approvals for multiple products in Southeast Asian markets while progressing with high-difficulty European registration and CER projects. We successfully assisted a Class III implantable medical device client in obtaining Ethics Committee (EC) approval for a First-in-Human (FIH) study. For a Class D high-risk lens implant product, the team secured rapid approval in only 3 months, demonstrating superior compliance quality and operational efficiency.

Productivity Reimagined via AI-Native Solutions

The launch of our self-developed China first CER AI tool at the end of 2025 officially marked the beginning of our "AI-native" era. This tool automates the entire chain from literature retrieval and depth analysis to report generation, reducing the traditional 80-hour work cycle to under 1 hour. By achieving a 97% 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 natural language customization and full data traceability to ensure medical rigor while redefining the efficiency boundaries of clinical evaluation. In the future, MDCE CRO will use CER AI as a starting point to comprehensively promote the intelligent reconstruction of business workflows, deeply integrating AI into registration filing, regulatory compliance, and clinical operations.

Scientific Synergy of Global Clinical Resources

Our global expert network achieved strategic growth of 32% in 2025, with deep scientific collaborations established with over 90 international PIs. We have constructed a global resource map distributed across Europe (61%), North America (25%), and the Asia-Pacific (14%), covering high-barrier sectors like cardiology, ophthalmology, gastroenterology, and hepatology. Additionally, the number of overseas partner medical institutions increased by over 30%, primarily in Europe (62%) and the Asia-Pacific (33%). This interconnected international network provides a solid foundation for Chinese enterprises to access cutting-edge research, accelerate multi-center project implementation, and push forward overseas market access and commercialization.

Steady Expansion of Overseas Talent

MDCE CRO's overseas team scale grew steadily in 2025, with nearly 20 core experts added across Europe, North America, South America, and Southeast Asia. Europe, as our core delivery region, 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 new team 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 possess professional backgrounds from top-tier international firms like Johnson & Johnson, AstraZeneca, and IQVIA. Their deep compliance literacy and international expertise significantly strengthen our ability to handle complex regulatory environments and ensure high-quality delivery.

2026 Outlook: Defining New Standards for Global Service

In 2026, MDCE CRO will continue to serve as a co-creator for global medical enterprises, building the core engine that connects frontier innovation with "Global Standards of Excellence." We will utilize our global expert teams and tailored strategies to help companies lock in the optimal path for overseas expansion within complex regulatory environments. By leveraging intelligent tools to increase efficiency and delivery certainty, we aim to help Chinese innovative pharmaceutical and medical device products build competitive advantages and benefit the world.