Company Team
The core members at LINKS CRO bring an invaluable wealth of experience from world-renowned top 500 MNCs, listed medical device companies, as well as well-known CRO companies. With their vast expertise in the field of class III and innovative medical devices, our team is highly proficient in delivering efficient and effective solutions with exceptional execution capabilities.
Martin Chen PhD
Founder of LINKS CRO
Graduated from ISCTE-IUL Medical Policy Management
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General Manager of LINKS, being responsible for the full operation of the company;
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Previously worked at Roche Pharmaceuticals and Lifetech Group;
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Nearly 20 years of clinical trial management experience, including CE-Mark studies in Europe and facilitated First-in-Man (FIM) clinical trials in Southeast Asia and China;
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Specialized in overseeing innovative device trials in various domains, including structural heart diseases such as TAVR/TMVR, VPD, and LAAC, as well as robotic technologies and more;
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A leading member of the Medical Device Professional Group within the esteemed "Smart Healthcare Entrepreneurship Association" at China Europe Business School
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Jack Hou
Chief Operating Officer
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20+ years clinical research industry experience
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Served at Multinational, Biotech and CRO companies, taking on the responsibilities of personnel, portfolio study and quality management, medical affairs, etc.
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Extensive hands-on experience in successfully managing studies on a global scale, with a particular focus on Asian and China local studies.
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Robert Pang
Director, Medical Affairs
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10 + years experience in medical device design and report writing
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Served at MNC pharmaceutical companies, possessing valuable FDA registration and declaration processes insights;
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Several innovative medical device design experience, including mitral valve replacement/tricuspid valve repair, TAVR, left atrial appendage occluder, various surgical systems, etc.
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Brian Liu
Senior RA Manager
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12-year background in both active and non-active medical device registration and Quality Management System (QMS) assessment Consultation
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Specialize in navigating the regulatory requirements and documentation necessary for the registration of medical devices;
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Well-versed in the intricacies of type-testing and evaluation concerns that arise during the CMDE (China Medical Device Evaluation) review process
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Ivy Huang
Senior CER Manager
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10+ years experience in the medical device industry of clinical evaluation and registration processes specifically related to class III implanted devices
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Well-versed in the registration regulations and requirements governing both active and non-active medical devices within the European Union and Southeast Asia.
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Young Yang
Senior Medical Manager
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Extensive experience of clinical trial protocol design for multiple innovative medical devices
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Served as a surgeon for 6 years at a prestigious hospital in China, gained valuable experience in surgical procedures and patient care;
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Contribute to the development of rigorous and well-designed clinical trial studies for multiple innovative medical devices;
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Authored and published over 20 articles in reputable SCI (Science Citation Index) journals.