China Clinical Trials,CRO Services for Medical Devices

China NMPA requires the local clinical data for product registration. The clinical evaluation materials to be submitted shall include clinical trial protocol and clinical trial report. Clinical trials that are conducted properly will facilitate a smooth registration approval process and expedite access to the China markets.

 

Our experts can help you manage and expedite your qualified clinical trials in China to get your products to market sooner:

 

  • Submit the application documents to China NMPA in accordance with related requirements;

  • Design clinical trial protocols;

  • Coordinate throughout the clinical trial process in Chinese clinical trial institutions.

 

Clinical Trial or CRO Consulting Services

 

GeBiao will provide clinical trial consulting services, including consultations with China governments. We can help you develop the best clinical trial strategy, clinical trial study design, and clinical trial protocol.

 

Regulatory Support

 

We can submit clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in China. Our on-the-ground teams consist of experienced China clinical trial professionals who will meet with the appropriate regulatory agencies on your behalf throughout the clinical study. We will provide guidance and help meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.

 

Clinical Trials Management

 

We can comprehensively undertake and manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our China CRO experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy requirements, along with primary and secondary endpoints, as required for your specific product.


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