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.

MDCE CRO Achieves Rapid EU PMCF Enrollment for Chinese CGM System, Accelerating European Commercialization

Overview

On October 1, 2025, MDCE CRO, in collaboration with an innovative Chinese medical device enterprise, successfully achieved the full enrollment target for the Post-Market Clinical Follow-up (PMCF) study of its self-developed Continuous Glucose Monitoring (CGM) system in the European Union. This project covers three clinical centers in Europe with a planned enrollment of nearly 100 patients. From the First Patient In (FPI) in July 2025, it took only two months to complete full enrollment, setting a new record for the rapid deployment of Chinese CGM devices in the European market. This study will further validate the long-term safety and efficacy of the product in the European population, enhancing its recognition at international academic and regulatory levels. Simultaneously, this not only meets the regulatory requirements for EU MDR certificate renewal but also provides strong support for the enterprise's commercial expansion in the international market.

Client Pain Points & Challenges

At the initial stage of the project launch, the enterprise faced triple pressures: EU PMCF study compliance design, cross-border multi-center coordination, and a tight timeline. A particularly thorny issue was that the product's companion application required a smartphone equipped with a lithium battery for data transmission, and strict international aviation transportation regulations for lithium batteries necessitated a complete reconstruction of the transportation plan. Furthermore, balancing the complexity of the ethics committee (EC) approval process in the target EU country with the efficiency of patient screening at the research centers posed a significant challenge to the project's advancement.

Project Highlights & MDCE CRO's Contributions

Leveraging extensive experience in European clinical trials, MDCE CRO provided critical support for the smooth progression of the project. In the compliance phase, the team aligned with MDR requirements from the protocol design stage. Combining this with the regulatory characteristics of the target country, MDCE CRO efficiently completed the preparation and submission of ethics and clinical documents, achieving EC approval in just one month—significantly ahead of the industry average.

In terms of resource allocation, the MDCE CRO team conducted detailed research to precisely screen centers and Principal Investigators (PIs). During the site initiation visits, we strengthened investigator training and optimized enrollment strategies and material management, ensuring the trial was conducted in an orderly manner under high standards.

Regarding logistics support, facing strict restrictions on the transport of devices containing lithium batteries, MDCE CRO coordinated international logistics and aviation resources within a tight project timeline to quickly complete the declaration for dangerous goods transport. We also designed a phased shipping strategy: an initial small batch was sent for physicians to use and learn, ensuring technical proficiency, followed by a second batch matched to enrolled patients to improve the quality of the clinical trial and data. This greatly shortened the project's preliminary preparation time and improved overall collaboration efficiency.

Additionally, the European summer holiday period often brings common challenges such as delayed return of researchers and decreased patient visit rates, which can easily impact enrollment progress. Relying on an efficient global project management and localized execution network, MDCE CRO anticipated these issues and developed response plans in advance. By flexibly allocating research resources and optimizing the enrollment process, we successfully resolved the post-holiday bottlenecks for personnel and patient enrollment, ultimately ensuring the project was completed successfully within the specified timeframe. This achievement fully demonstrates MDCE CRO's professional strength and execution resilience in overseas clinical projects. Thanks to the synergistic efforts across these areas, the project not only achieved its first enrollment smoothly in July but also efficiently completed the full patient enrollment target within two months.

Future Outlook

The advancement of this PMCF study will further validate the safety and efficacy of the product in the European population. This not only ensures the product complies with EU MDR regulations but also opens the pathway for the enterprise's certificate renewal in the EU market. Meanwhile, through the implementation of this project, the enterprise will have the opportunity to establish long-term strategic partnerships with European clinical centers and Key Opinion Leaders (KOLs), further enhancing the international competitiveness of this Chinese CGM product in the field of diabetes management and boosting its brand reputation and commercial expansion.

As a globalized partner deeply engaged in the industry, MDCE CRO understands that PMCF is not only about regulatory compliance but also relates to a company's long-term and steady international layout. The successful completion of full enrollment for this EU PMCF study fully reflects MDCE CRO's highly efficient execution and professional assurance in overseas clinical research. Looking ahead, MDCE CRO will continue to leverage professional, efficient, and customized services to partner with more Chinese medical device enterprises, enabling innovative achievements to cross borders and benefit patients worldwide.

Dermatology First-in-Class Product Initiates Phase II Clinical Trial in Australia

Overview

In May 2025, MDCE CRO's innovative drug overseas service solution, Jeanne, successfully assisted a leading innovative pharmaceutical enterprise's breakthrough innovative candidate drug, a dermatology First-in-Class product's Phase II clinical trial project in successfully completing the Site Initiation Visit (SIV) at a research center in Australia, injecting strong momentum into the compliant and efficient advancement of the project. The project plans to conduct clinical trials for dermatology patients across three clinical research centers in Australia and aims to recruit at least 28 patients by the end of September. Currently, MDCE CRO has smoothly obtained ethics approval and completed the SIV for the Australian centers, and is rapidly advancing patient enrollment. Simultaneously, it will continue to deepen close collaboration with various research centers and Key Opinion Leaders (KOLs) in Australia, laying a solid foundation for advancing to global Phase III clinical trials or conducting other related research in the future.

Initiating the first clinical research center and launching this overseas multi-center clinical trial in Australia marks an important milestone for this innovative pharmaceutical enterprise as it steps into the international market. MDCE CRO's Jeanne solution also powerfully demonstrates its outstanding capability and efficient execution in providing affordable overseas solutions. Over the past five years, the Jeanne solution has successfully helped 23 innovative drug projects land overseas, covering countries and regions including the United States, Australia, Singapore, Hong Kong, the Middle East, and Southeast Asia, managing over 500 patients cumulatively. In 2024, one project successfully completed its Phase II trial and advanced to the global Phase III stage, vividly practicing the mission and vision of bringing medical innovation to benefit the globe.

Project Highlights

As the core partner of this innovative pharmaceutical enterprise, MDCE CRO relied on its profound professional accumulation to provide end-to-end professional support for the Phase II clinical trial of its breakthrough innovative candidate drug in Australia. We not only ensure the efficient and high-quality advancement of the project but also consistently integrate the mindset of accelerating the drug launch process and maximizing commercial potential throughout the entire lifecycle.

Building a Solid Foundation for Trial Compliance and Efficiency

During the initiation process of the Australian research centers for this project, the MDCE CRO team implemented refined management across the entire project implementation lifecycle. In the project initiation phase, the team strictly followed Australian regulatory standards to build preliminary document systems such as the review protocol and informed consent forms, ensuring the compliant advancement of the project. In terms of drug management, the team exercised precise control to ensure a stable material supply and safeguard trial continuity. Through full-process control, MDCE CRO not only ensures the efficient and compliant operation of overseas clinical trials but also consolidates the document foundation for future marketing applications, significantly reducing compliance and delay risks.

Empowering Research Centers to Drive High-Quality Data Generation

Relying on abundant clinical resources in Australia, the MDCE CRO project team efficiently screened multiple leading target centers in the dermatology field. At the Site Initiation Visit (SIV) meeting organized by MDCE CRO, the project's Principal Investigator, the research center's Clinical Research Coordinators, the sponsor's executives, and the MDCE CRO project team attended together. During the meeting, the project team conducted comprehensive and in-depth training on investigational drug characteristics and trial procedures, and unified operational standards. These initiatives not only laid a data compliance foundation for the product's clinical advancement but also provided a replicable paradigm for subsequent center initiations, accelerating the overall project process.

Helping to Maximize Commercial Value

From the project's inception, MDCE CRO placed commercial success at the strategic core, empowering the global value realization of the client's product through a forward-looking layout. The team collaborated with the client to formulate the market positioning and optimal access pathway for this dermatology product in Australia and globally, and efficiently initiated overseas core research centers to ensure the rapid acquisition of high-quality clinical data. This will significantly shorten the product's time-to-market, helping the enterprise seize the initiative in the global dermatology field. By building academic barriers and planning clear commercialization pathways, MDCE CRO will continue to help clients achieve a maximized harvest of commercial value.

MDCE CRO Secures Third Singapore Clinical Trial Approval for MedTech

Recently, MDCE CRO successfully facilitated an international multi-center randomized controlled clinical trial for a Chinese medical device enterprise, securing Singapore IRB approval through its professional support. This marks the third time MDCE CRO has assisted a Chinese enterprise in successfully obtaining approval for a post-market clinical trial in Singapore. The trial aims to compare the safety and efficacy of two innovative medical devices, one of which is already approved for marketing in Singapore. Leveraging high-quality clinical data from Singapore, MDCE CRO will help accelerate the commercialization layout of both products in the Singapore market, laying a solid foundation for future entry into European and American markets, while providing strong support for the rapid sales volume growth of the already marketed product.

Project Background: International Multi-Center Randomized Controlled Trial

The approved project is an international multi-center, randomized controlled clinical trial designed to compare the safety and efficacy of two innovative medical devices. It covers six centers in China and one center in Singapore, with a planned enrollment of approximately 150 subjects. In China, both products of this project are already on the market, requiring relatively lower design and resource investment. However, in Singapore, while one product has been approved for marketing, the other remains unapproved and is classified as a high-risk medical device, thus requiring higher standards of ethical review. This discrepancy posed a significant challenge to the project while also providing a stage for MDCE CRO to demonstrate its professional capabilities.

Project Challenges: Precise Breakthroughs Amidst Strict Regulations and High-Efficiency Execution Requirements

On May 10, 2024, Singapore launched the Ethics and Compliance Online System (ECOS), replacing the original NHG ROAM system to cover the management of the entire research lifecycle. However, technical issues during the initial launch phase led to a backlog of ethics review applications. It was not until September 2024 that the system was gradually improved, and various procedural obstacles were still encountered during the application process. At the same time, following standards for high-risk device clinical research, the Singapore IRB raised nearly 20 inquiries regarding the trial protocol, covering inclusion/exclusion criteria, patient populations, informed consent forms, CRFs, risk management plans, and DSMB configurations. Since the project's medical and data management were handled by other companies, cross-departmental and even cross-company communication and coordination further exacerbated the project's complexity, bringing immense challenges to the MDCE CRO team.

Project Highlights

Precise Strategy Design and Efficient Regulatory Communication: Based on extensive experience in international multi-center clinical trials, MDCE CRO conducted a comprehensive review of the project's trial protocol and proposed professional revision suggestions to ensure compliance with Singapore's regulatory and ethical requirements. Facing multiple rounds of inquiries from the IRB, the team demonstrated outstanding communication skills. For the first round of nearly 20 questions, they conducted detailed analysis and cross-departmental discussions, ensuring accurate and timely responses and completing the initial reply as scheduled. In the second round of inquiries, relying on previous extensive experience with Singaporean institutions and deep professional capabilities, MDCE CRO completed all responses and updates in just two working days, significantly shortening the approval time.

Cross-Team Collaboration and Review Efficiency Improvement: Under the circumstance of review backlogs caused by technical issues during the initial launch of the new system, MDCE CRO overcame procedural obstacles through close collaboration between the project team and the sponsor. They submitted the ethics review application in a timely manner and successfully caught the Full Board Review meeting on October 1, 2024.

Commercialization Strategy and Market Expansion Support: Relying on a profound understanding of overseas commercialization strategies and abundant local physician resources in Singapore, MDCE CRO provides strong support for the sales volume growth of the approved marketed product in Singapore. By organizing multiple product training sessions and academic seminars, MDCE CRO built bridges allowing local doctors to quickly familiarize themselves with product characteristics and clinical applications, helping the client's product rapidly open the Singapore market, achieve commercialization, and further advance into European and American markets.

Client Benefits: Accelerating Global Market Layout

The successful approval of this clinical trial in Singapore marks significant progress in the client's global market layout. As a global hub for medical innovation, Singapore's clinical trial data enjoys high international recognition, laying a solid foundation for the client's overseas market expansion. More importantly, relying on MDCE CRO's deep integration into local physician resources and Singapore's high-quality clinical data, the sales volume of the client's marketed product in the Singapore market is expected to significantly increase. This further promotes the product's market penetration and patient coverage, providing robust support for the client's global commercial success.

Looking Ahead: A New Milestone in the Globalization of Chinese Medical Technology

The successful approval of this clinical trial in Singapore is not only another manifestation of MDCE CRO's professional capabilities in global clinical trials but also an important milestone for Chinese medical innovation enterprises stepping onto the world stage. Next, MDCE CRO will fully advance the trial center initiation and first patient screening work for this project, planning to complete it by the end of February 2025 to ensure the trial smoothly enters the substantive phase. In the future, MDCE CRO will rely on its deep network of local physician resources across Europe, the Americas, and the Asia-Pacific region to further promote the overseas market penetration and patient coverage of Chinese medical devices and pharmaceutical products, accelerating sales growth in the global market and providing continuous support for the global commercial success of our clients.

MDCE CRO Secures Multiple FDA Breakthrough Device Designations to Accelerate Premium International Market Entry

Overview

According to incomplete public statistics, only 19 enterprises in the region have successfully obtained FDA BDD to date. MDCE CRO has successfully assisted four clients in obtaining FDA Breakthrough Device Designations, covering high-potential fields such as cardiovascular, orthopedics, and gastrointestinal interventions. This achievement not only lays a solid regulatory foundation for clients' products to enter the US market but also significantly enhances the enterprise's international market competitiveness and influence through the FDA's authoritative recognition, providing an important strategic anchor for their global market expansion. Currently, MDCE CRO is rapidly advancing another eight FDA BDD projects, continuing to empower innovative medical device enterprises going global.

 (Image placeholders for official FDA letters) 

(Image placeholders for official FDA letters)  

Selected MDCE CRO FDA BDD Cases

Project Highlights and Breakthroughs

During the FDA Breakthrough Device Designation application process, enterprises often face multiple challenges that increase certification difficulty and may affect the product's market window and launch process. For example, initially submitted materials may struggle to effectively support the product's innovative advantages in terms of data support and logical reasoning. Meanwhile, the competitive environment is fierce, and enterprises often face situations where similar products are already on the US market, thus they must fully prove significant advantages in their product's innovation. Furthermore, the application experience of the partner organization is crucial; a lack of BDD application experience can easily lead to significantly extended project cycles, and low-quality submissions will also affect the enterprise's credibility with the FDA. As innovative medical device enterprises accelerate their global market layout, the FDA's review standards for breakthrough medical device certification applications have become stricter. Enterprises must pay more attention to material quality, compliance, and effective communication with the FDA when submitting applications.

Future Vision

Driven by professionalism and innovation, MDCE CRO is committed to being a solid backing for the global layout of medical enterprises. We will continue to assist more innovative medical products in their FDA Breakthrough Device Designation applications, looking forward to achieving more breakthroughs in high-potential fields and comprehensively enhancing international competitiveness. Looking ahead, MDCE CRO will work hand in hand with more innovative medical enterprises to bring more efficient and safe medical solutions to global patients, truly realizing the vision of allowing medical innovation to benefit the globe.

Innovative Magnesium Alloy Cannulated Screws Earn FDA Breakthrough Designation with MDCE CRO's High-Quality Submission

Overview

Recently, the FDA's review standards have become increasingly strict for breakthrough medical devices originating from China. Some Chinese enterprises have had their applications rejected due to substandard submission materials or reliance on low-quality partner agencies, which has even negatively impacted their credibility with the FDA. Against this backdrop, MDCE CRO on January 1, 2025, once again leveraged its outstanding global medical device registration services to successfully assist a client's controllably degradable Magnesium Alloy Cannulated Screws in obtaining the US FDA Breakthrough Device Designation (BDD). This achievement signifies that the product's innovation and clinical value have been highly recognized by international authorities, further proving MDCE CRO's professional capabilities in high-quality submissions and global registration services. This approval sets a technical benchmark in the global orthopedic implant field and provides a strong demonstration effect for the Chinese orthopedic medical device industry to break through into the high-end international market, propelling Chinese innovative technologies to occupy a more prominent position on the global healthcare stage.

 (Official letter from the US Food and Drug Administration (FDA)) 

FDA Tightens Certification Standards: Chinese Companies Must Improve Submission Quality and Value Corporate Credibility

As Chinese innovative medical device companies accelerate their global market expansion, the US FDA has applied stricter review standards to their applications for Breakthrough Device Designation. Some companies have faced rejection due to insufficient material quality, inadequate data support, or incomplete communication with the FDA, ultimately harming their credibility. The FDA's tolerance for low-quality submissions is gradually decreasing, and the review process is becoming increasingly strict, which requires Chinese enterprises to pay greater attention to material quality, compliance, and effective communication with the FDA when submitting applications.

As a CRO specializing in global medical device registration and clinical trial services, MDCE CRO always adheres to the principles of high quality and high standards to help clients meet the FDA's rigorous review requirements. The successful certification of these Magnesium Alloy Cannulated Screws is another testament to MDCE CRO's high-quality submission and global registration services.

Breakthrough Device Designation: Accelerating the Launch of Innovative Medical Products

The FDA's Breakthrough Devices Program aims to accelerate the development and approval process for innovative medical devices that provide more effective treatment for severe or life-threatening diseases. Devices receiving this designation enjoy FDA priority review, more frequent communication and guidance, and a more flexible review process, thereby significantly reducing time to market.

The client's Magnesium Alloy Cannulated Screws successfully obtained this designation thanks to their outstanding performance and innovative design in orthopedic surgeries.

The product utilizes industry-leading controllably degradable coating technology, achieving a precise match between bone healing and implant degradation through breakthrough biocompatibility and degradation control, effectively solving multiple pain points associated with traditional metal implants. The product possesses superior mechanical properties, with tensile strength surpassing pure titanium, providing stronger support for fractures. Concurrently, its precise degradation technology ensures the implant degrades stably during the critical period of bone healing, effectively avoiding complications. Furthermore, magnesium, as an essential element in bone tissue, offers high biocompatibility and can be gradually degraded, significantly reducing the risk of postoperative infections.

 (Product Illustration) 

MDCE CRO: A Reliable Partner for Global Medical Device Clinical and Registration Services

As a CRO focused on global medical device clinical trials and registration services, MDCE CRO is committed to providing comprehensive registration services for innovative medical device companies. From regulatory consulting and material preparation to communication and coordination with the FDA, MDCE CRO relies on its extensive experience and professional team to help clients efficiently navigate the complex regulatory environments of the global market.

In this project, MDCE CRO worked closely with the client to ensure that the submission materials for the Magnesium Alloy Cannulated Screws fully complied with the FDA's strict requirements. MDCE CRO's rich global resources and professional local teams provided strong support for the client's smooth acquisition of the breakthrough device designation.

Project Highlights & MDCE CRO's Contribution

Because the United States currently has magnesium alloy products on the market treating the same indications, this application was highly challenging. MDCE CRO participated in every step of the project, from strategy formulation to material submission. The main contributions included:

Looking Ahead: Chinese Medical Innovation Goes Global

The approval of this Breakthrough Device Designation will accelerate the future FDA regulatory and review process for the Magnesium Alloy Cannulated Screws, effectively shortening the time to market. At the same time, this approval highlights the technological leadership and market competitiveness of the Magnesium Alloy Cannulated Screws in the global orthopedic implant field. It serves as an important milestone for the company as it steps onto the world stage and expands its global footprint, establishing a crucial benchmark for Chinese innovative medical device companies aiming for internationalization. Moving forward, MDCE CRO will continue to support more Chinese innovative technology companies in achieving their international expansion through high-quality overseas clinical trial and registration services, thereby contributing to the globalization process of Chinese medical technology.

MDCE CRO Successfully Facilitates EU PMCF Study for High-Risk Class III Medical Device

Project Overview

In November 2024, MDCE CRO empowered a leading Chinese regenerative medicine enterprise to complete enrollment for an international multi-center PMCF study for its absorbable hemostatic material, successfully advancing the project to the Database Lock (DBL) phase.

The study spanned three European nations—Italy, Latvia, and Bulgaria—with 149 patients enrolled within an 11-month timeframe. The database lock is projected to be finalized within the current month.

This accomplishment provides the manufacturer with robust clinical data to support its global market strategy, highlighting the growing recognition of Chinese medical innovation on the world stage. It further underscores the indispensable role of a skilled CRO in facilitating the successful commercialization of Chinese medical technologies abroad. MDCE CRO remains committed to bridging the gap for Chinese healthcare innovators, ensuring that high-quality medical advancements benefit patients worldwide.

I. Strategic Approach

II. Comprehensive & Agile Execution

Project Significance & Outlook

The successful completion of this project validates the safety and efficacy of the product in clinical practice, providing a powerful catalyst for international commercialization.

Regulatory Compliance: Under the EU Medical Device Regulation (MDR), PMCF is a mandatory requirement. Achieving this milestone provides the essential clinical data needed to maintain CE certification, ensuring uninterrupted market access.

Commercial Growth: For the sponsor, this project is a strategic win, enabling the expansion of sales channels, increased market share, and a stronger global brand presence.

This achievement marks a pivotal step in the sponsor’s globalization strategy, setting a new benchmark for Chinese medical innovation in the international arena.