Clinical Trials Project

Introduction: In order to verify basic research innovations in human body, clinical trials will be executed in medical centers. To ensure the quality of clinical trials and the compliance of Good Clinical Practice (GCP), each trial will be monitored by contract researched organization (CRO) and be audited by professionals with various specialties under the management of the Clinical Group.
The clinical trials, the objects of the domestic development of new drug with commercial value, new medical device and new medical technology, have high priority in the all candidates. Moreover, investigator-initiated trials are encouraged to apply.
 
Scope:

  1. Clinical trial for western medicine
    1. Get national/international patent; have finished preclinical pharmacological/pharmacodynamic study, and safety study; be able to enter human study
    2. Biologics, including vaccine & biosimilar research
    3. New indication, new compound, new formulation and new route of administration
      • Has got domestic and foreign patents; the technology development of preclinical drug with patent rights which belongs to the second class of new drug; clinical trials with a market niche; products potentially to market as first priority
      • Potential to get international patents (please provide patent search related information) the second class of new drugs-related technology development (including listed molecules and proteins drugs), or clinical trials with market niche

 

  1. Clinical trial for medical device including IVD
    1. Has finished preclinical pharmacological/pharmacodynamic study, safety data, and about to enter clinical study
    2. Diagnostic kits, testing reagents, chips

 

  1. Clinical trial for new medical technology
    • Has finished preclinical pharmacodynamics and safety data, and about to enter clinical study

 

  1. Clinical trial for botanical drug & Chinese herbal medicine (new drugs with new compound, new usage, or partial purify etc...
    1. Adjuvant treatment: reduce side effect or have lower side effect; able to replace expensive drugs; medical treatment such as for difficult-to-treat diseases or providing more effective than western drugs, concerned as first priority
    2. Drug-drug interaction studies involving Chinese herbal medicines with western medicines