Clinical Trials

Proswell medical maintains integrated Standard Operating Procedures in compliance with GCP. We conduct clinical studies strictly in compliance with local regulation and laws, GCP, and Proswell medical’s SOP, to provide valuable services for customers and to obtain qualified clinical data. Clinical trial strategy development, Management and Implementation.

 

•Execution Plan of Clinical Trails

•Clinical Trial Management

•Audit

The Quality Assurance Department of Proswell Medical Company was established in December 3rd , 2010, which is independent of the Clinical Operation Department to implement the auditing works, evaluate the quality of clinical trial, ensure the processes of clinical trial in accordance with the requirements of protocol, SOP, GCP and relevant laws and regulations, safeguard the rights and interests of subjects, ensure the scientificity and reliability of clinical trial data;

There are 6 staff in Quality Assurance Department of Proswell Medical Company at present, with an average of 5 years working experience related to clinical trial, and at least 2 years auditing experience, auditors are familiar with relevant laws and regulations and guidelines for clinical trials , and understand the relevant treatment guidelines;

The present services provided by Quality Assurance Department of Proswell Medical are as below:

On site Audit of Clinical trial;

Document Verification of Clinical trial;

Auditing Service of Pre-inspection Processed by Regulatory Agencies

Since 2011, the Quality Assurance Department of Proswell Medical Company was entrusted by sponsors and Drug Clinical Trial Institutions to implement 32 auditing items, the covering therapeutic areas include: cardiovascular, cancer, endocrine, neurological, psychiatric, Gastroenterology, etc.., which are distributed as below:

 

Through our professional, independent, objective auditing services, we are able to assess the quality of clinical trials for customers, initiate timely corrective and preventative action accordingly, avoid the quality risk in process of clinical trial, and improve the quality of clinical trials