Having rich database resources and experienced statisticians, Expro clinical analysis and evaluation team can analyze and evaluate products professionally, comprehensively and objectively in accordance with the laws and regulations of the National Medical Products Administration (NMPA) and prepare clinical evaluation reports.
Expro specializes in selecting the reference product for the subject product intended to be registered with NMPA for comparison, judging and determining the identity of the subject and the reference, and searching and collecting clinical data through various means with the cooperation of statistician.
Expro has rich and comprehensive product database resources, including PubMed, Google, Ovid, ISI, Cochrane Library and other major domestic and international databases, as well as clinical trials and registration database, which can enable Expro clinical analysis and evaluation team to retrieve the related literature and clinical trial data efficiently for statisticians to implement META analysis and evaluate the safety and effectiveness of the products.
Clinical evaluation report based on clinical trial data and clinical application data includes:
1.Judgement and determination of the identity of the subject and the reference
2.Evaluation path
3.Analysis and evaluation
4.Analysis on the clinical trial data or the clinical application data of the reference
Clinical literature data set includes:
1.Complaint and adverse event data set
2.Chinese population data set
3.Analysis and evaluation of above data sets
4.Conclusion
and etc.
