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