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Hangzhou Clinda CRO, established in January
2005, has been operating for more than a decade with an office in China’s major city of Hangzhou, where G20 summit was held in 2016. As one
of the first founded CROs in China, we commit ourselves to high-quality
service, ranging from monitoring clinical trials of medical device to CFDA registration. Major
employees graduated from famed universities of the country, with working
experience in large corporation and a particular focus on medicine.
Our
people
Our team includes: clinical trials of
medical device, medical writing department, data management and statistical
analysis, registration of medical device, management department.
CRA: all with qualification of GCP issued
by CFDA, minimum education of bachelor’s degree in
medical universities (project manager with over 5 years’ practical experience in clinical trials)
Medical writing: a minimum of master’s degree in clinical medicine
Registration department: all with at least
5 years relevant work experience in registration and GMP(Good Manufacturing
Practices)
Our
leadership
Junqing Xiang, chief medical director and
president, clinical trials
Xiang has more than 20 years of clinical trials
experience and a proven track record of operational leadership and professional
technique. Prior to joining Clinda, he served as resident doctor in the children’s hospital affiliated to medical school of Zhejiang University. Previously,
Xiang was appointed to chief medical director successively in Hangzhou Tigermed
Consulting Co. and ASKLEP CRO, the top 3 CRO in Japan.
Xiang holds a Master of Science degree in
internal medicine from Shanghai Medical University (Fudan University) and a
bachelor of science in medicine from Zhejiang Medical University (Zhejiang
University).
Qiuyu Ji, head of registration department
Ji has held positions in big companies
including medical device facility and clinical corporation in Beijing.
She received a master degree from South China
University of Technology in 2009.
Our service
Clinical
trial of medical device
1. Medical writing
Preparation of element clinical trial
documents (protocol, informed consent, etc.)
Clinical trial summary report writing
Clinical trial interim report writing
Investigator’s Brochure
2. Ethical submission
Submission on paper & electronic
submission
Communication with Ethics Committee
3. Clinical monitoring
Initiation meeting
Regular monitoring
Close visit
Submission
of monitoring report
4. QA for Clinical trial
Auditioning according to the customer
request or SOPs of Clinda.
5. Data management and Bio-statistical
analysis
Provide statistical analysis report
according with CFDA standard
6. Clinical evaluation report of
medical device
Meta-Analysis
Summary report writing
7. Project management &
assistance
Manage the clinical trial operation system
Establish standard operation procedures
Perform document filling
CFDA
Registration of medical device
1. License application of medical device
II, III
2. Registration of imported
medical device
3. licensing agent for medical device
management
4. consulting for GMP (Good
Manufacturing Practice) of medical device
5. Providing guidance on quality-managing
system for medical device enterprise.
6. Registration agent for IVD II,
III
7. Inspection service on medical device
or related fields.
Experience
With more than 100 cooperative hospitals,
we have helped develop or complete over 160 clinical trials and registration.
And it’s all done with an unwavering dedication to high
quality, in the pursuit of perfection.
Projects cover the following indications or
therapeutic category:
1. Drugs
HBV (viral hepatitis type B), PU (peptic
ulcer), DGIM (gastrointestinal kinetic disorder), fatty liver,
hypercholesterolemia, EH (essential hypertension), colon cancer, myeloid
leukemia, cerebral vascular accident and rehabilitation, type II diabetes, cold,
COPD, antibiotic, osteoarthritis, urinary calculus, allergic rhinitis,
urticarial etc.
2. Medical device
Fixed prosthesis, removable prosthesis,
orthodontic bracket, invisible bracket, appliance, zirconium dioxide, orthodontic
pliers, intraocular lens, reshaping contact lenses, electronic
sphygmomanometer, sphygmomanometer, electronic thermometer, infant incubator,
hepatopathy treatment device, ureteric endoscope, a variety of hemostatic
products, SH (sodium hyaluronate), disposable insulin needle, disposable venous
indwelling needle, ozone therapy instrument, ultrasound drug permeability
apparatus, ocular viscoelastic, arterial embolic agent, ligating clamp, diagnostic reagent, bacteria medium
and selection medium, spinal internal fixation, laser location instrument for
orthopedics, disposable infusion apparatus, infusion monitor, amblyopia therapeutic instrument, thermal radiation
therapeutic instrument, liquid dressing, gargle, care solution for contact
lenses, lubricant etc.
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