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.