Registration for MD and IVD reagents in CFDA includes registration test, clinical trial and products registration. Clinical trial is the second step.

 

Haimiao has great advantage in clinical trial, include:

1. Wide co-operation clinical bases, including Peking Union Medical College Hospital, Peking University First Hospital, Peking University People’s Hospital, Beijing Tongren Hospital, Beijing Youan Hospital, Beijing Chao-Yang Hospital ,Beijing Anzhen Hospital, Beijing Tiantan Hospital, 302 Military Hospital of China, Beijing Ditan Hospital, Capital Institute of Pediatrics, etc. 

2. More than ten years’ clinical experience in various IVD reagents, including allergen, infectious disease, virus, biochemistry, tumor marker, microbiology etc. 

3. Successful experience in clinical trial for new IVD reagents, including HE4,Allergen,etc.

 

Clinical services provided by the Haimiao include:

1. Contact qualified clinical trial institutions to conduct clinical trials.

2. According to the product characteristics, help drafting the clinical protocol.

3. Guide customers to prepare data for ethical review and obtain ethical approval.

4. Help drafting clinical cooperation agreement between clients and clinical institutions.

5. Responsible for the monitoring of clinical trials.

6. Track the progress of clinical trials, and obtain clinical reports.

 

Clinical period: General 6-12 months, significant differences based on different products.