HiEagle Medical Successfully Completes EU PMCF Trial for a Chinese-Listed Company’s Class III High-Risk Absorbable Hemostatic Device and Enters Database Lock Phase

In November 2024, MDCE CRO assisted a leading domestic regenerative medicine device company in efficiently completing the international multicenter PMCF study for one of its absorbable hemostatic materials.All cases were enrolled.and smoothly advance the projectEnter the Database Lock (DBL) phase.This study, covering three European countries—Italy, Latvia, and Bulgaria—rapidly completed the enrollment of a total of 149 patients within 11 months, with database lock expected to be finalized within this month.

The successful advancement of this PMCF project not only provides robust clinical data support for the company’s global market strategy, fully demonstrating the growing recognition and influence of innovative Chinese medical devices in the international arena, but also reaffirms the indispensable role of CROs in facilitating the overseas expansion and commercialization of healthcare enterprises. “Progress must be made even from a high vantage point; the entire universe is within one’s reach.” MDCE CRO remains committed to helping more Chinese healthcare companies expand globally, ensuring that China’s medical innovations benefit people worldwide!

 MDCE CRO and the Principal Investigator Jointly Reviewed and Signed Study Documents

MDCE CRO, with its international team and extensive overseas clinical experience,Assisted the sponsor in accurately and efficiently completing country selection and site selection during the project initiation phase.Regarding country selection, in addition to Italy as designated by the sponsor, MDCE CRO has added Bulgaria and Latvia as study sites, based on comprehensive considerations including the requirements of the European multicenter PMCF project, overall project benefits, and risk management. Latvia and Bulgaria possessA relatively mature clinical trial environment and high patient recruitment potentialMeanwhile, MDCE CRO has its own strong overseas expert team locally, which can cooperate with the project efficiently and flexibly, significantly improving project benefits. In addition, based on past experience, to address challenges such as slow recruitment progress that may arise in Italy, MDCE CRO has selected Bulgaria and Latvia as priority countries for patient enrollment. This approach helps mitigate risks while ensuring the achievement of commercialization requirements and the smooth progression of the project.

Leveraging its extensive overseas hospital resources and dedicated local teams, MDCE CRO rapidly identified and activated multiple high-quality research centers, enabling timely project initiation and efficient patient recruitment. Through precise site selection, MDCE CROReduced potential data processing and analysis challenges during the project, ensuring high quality and reliability of clinical data.

In terms of submission strategy, MDCE CRO adopted a parallel submission strategy across three countries, demonstrating strong project management capabilities and further saving time costs for the sponsor.

MDCE CRO’s in-house medical teams in Latvia, Bulgaria, and Italy have provided the project withComprehensive support covering all stages, including study protocol submission, ethical approval, patient recruitment, and clinical monitoring.

By providing Medical Monitor services, MDCE CRO further ensured the project'sProject Safety and Compliance.This initiative not only optimized clinical monitoring processes, ensuring rapid and compliant project advancement across countries, but also significantly improved resource utilization efficiency.Facilitated the smooth conduct of high-quality research at a lower cost.

Leveraging precise patient recruitment strategies, MDCE CRO rapidly advanced and completed patient enrollment. This was particularly evident in Latvia and Bulgaria, where MDCE CROComplete 50% of patient recruitment and enrollment within three months after project initiation.Despite encountering certain practical recruitment challenges in Italy, the situation remains within the scope of MDCE CRO’s preliminary risk assessment. MDCE CRO has flexibly adjusted its strategy and filed a protocol amendment to transfer part of the enrollment quota to sites in Latvia, ensuring the efficient progress of the overall project without compromising its outcomes.

During the project implementation in Italy, despite encountering common local issues such as delays in the review and signing of research contracts, MDCE CRO formulated ethical guidelines compliant with local regulations and leveragedThe local team closely monitors the progress of hospital approvals., ultimately ensuring the smooth progress of the project and demonstrating MDCE CRO’s exceptional management capabilities and agility in multinational clinical trials.

The successful advancement of this project not only demonstrates the safety and efficacy of the product in clinical applications, but also significantly promotes its commercialization in the international market. FromRegulatory LevelSee, PMCF StudyIt is a mandatory requirement under the MDR., the successful completion of the project provided critical clinical data support for maintaining the product’s CE marking, ensuring its compliance in the European market. Meanwhile,At the commercialization level,Through this project, the sponsorFurther expanded sales channels and market share, significantly enhancing brand influence and market competitiveness, thereby laying a solid foundation for future global market expansion. The successful completion of this project marks a significant step in the sponsor’s globalization strategy, not only helping it gain greater recognition in the European market but also further deepening its global business layout, setting a new benchmark for promoting Chinese medical innovation on the international stage.

MDCE CRO is a pharmaceutical and medical device R&D outsourcing service company with global clinical trials as its core business. Leveraging Harvard University’s global medical research resources and academic influence, MDCE CRO has established a comprehensive overseas service value chain, providing customized global expansion solutions for Chinese biopharmaceutical and medical device enterprises. Its services encompass overseas clinical development strategy and design, overseas clinical trial management and operations, overseas product registration, and overseas commercialization layout. Since its inception, MDCE CRO has successfully facilitated the overseas launch of more than 60 biopharmaceutical and medical device 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.

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