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Zhiping Li

Clinical Study Manager, IVD

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Zhiping Li has more than 10 years of experience with in vitro diagnostics (IVDs). He gained his understanding of product design and development while working as a researcher in a local Chinese local company. He then became familiar with the management requirements of IVD clinical trials in hospitals through his work at a local clinical research organization (CRO) and Abbott. Zhiping received his degree from Yanshan University (Qinhuangdao, China) in 2009, with a major in biological engineering.

CORE COMPETENCIES

  • Managing IVD clinical trials
  • Clinical trial strategy, design and implementation
    • Incorporating targeted strategies to lead to optimal global submission pathways
    • Efficient site selection, onboarding, protocol development, patient enrollment and interfacing with institutional review boards
    • Decreasing time to market by streamlining department standard operating procedures (SOPs), goals, objectives and systems
  • Therapeutic expertise with infectious diseases, cancer biology, cardiovascular, drug concentration test, microbiological detection

RECENT PROJECTS

  • Biochemical reagents
  • Enzyme-linked immunosorbent assay (ELISA)
  • Clinical Laboratory Improvement Amendments (CLIAs)
  • Point-of-care tests (POCTs)
  • Coagulation tests
  • Urine analysis
  • Immunohistochemistry
  • Microbial culture and identification
  • Antimicrobial susceptibility test