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Clinical Investigation(or Clinical Trial)

Clinical investigation is an unpredictable step within registration application duration, which need much more time and investment. We help our clients make accurate prediction from very beginning to avoid any incidents and reprocessing. Our dependable operating and management system with strict SOP of quality control  can ensure every project run smoothly.

Our service about clinical investigation covers many fields such as IVDs, orthopedics, radiology, medical imaging, diagnose and nursing, physiotherapy, stomatology, ophthalmology, gynaecology and obstetrics, medical software, active and passive implant medical device etc. There are 120 hospitals that have long-term partnership with us as the study sites. Until now this number is still being increased. We are trying to provide our clients much more choice as possible as we can.

We have operated and completed many registration and clinical trial projects, and some of those projects are even initiated in China or Asia at the first time based on our higher professional competence than other competitors. We believe efficiency and result of clinical investigation should be decided by professional personnel with specialized knowledge about certain product. For this purpose, we have recruited many professional staffs with relevant qualification to ensure scientific management and distribution. At the same time, our professional team can cover the fields such as biometrics, medicine, consultation of regulations, data management etc. and provide additional value to serve the clients better. We insist on integrity and responsibility to gain trust and cooperation from our clients.


Our service expierence for IVD

  • Automatic and Rapid microbial mass spectrometry test system
  • Human papillomavirus genotyping test kit
  • HIV antibody detection test kit
  • Non-small-cell lung cancer-related antigen test kit
  • Aneuploidy of fetal chromosome test kit
  • Human leukocyte antigen genotyping test kit
  • Immunoglobulin of thyroid stimulating hormone test kit

Our service expierence for active medical device

  • Neurosurgical robot navigation system
  • Fundoplication surgical system
  • Brepho-first aid respirator
  • HF therapeutic system
  • Intraoperative radiotherapy system
  • Ho :YAG therapeutic system
  • Analgesia infusion pump


Our service expierence for Class Ⅲ implant/Interventional passive medical device

  • Artificial hip joint/ knee joint/ intervertebral disk
  • Biological dural patch
  • Sodium hyaluronate gel
  • Hemodialysis concentrate
  • Degradable hemostatic powder/ gauze/ sponge
  • Medical collagen-hydroxyapatite artificial bone meal
  • Absorbable suture
  • Dental implant system


Service Items

Clinical investigation sites screening

Clinical investigation plan design

Ethical materials preparation

Clinical investigation monitoring

CRC(clinical research coordinator

Data statistical analysis

Clinical report

Clinical data review


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