During the development of a new product, clinical trial takes the most time and cost. Therefore, how to reduce avoidable mistakes, and get high-quality results in the shortest possible time, is the question before the commencement of clinical trials that requires careful decisions. With the advantages of QME expertise, you can achieve more with less investment.

QME is able to reduce the cost and bring fast, high-quality, convenient and low-risk services to our customers with our expertise on international practices and guidelines for medical device clinical trials. It is achieved through standardized implementation and supervision, effective coordination of authorities, experts, clinical research units and testing facilities, and optimized planning of medical device clinical trials.

Our advantages:

•       Proficient in medical device clinical trials related regulations and implementation details;

•       Understand international practices and guidelines for clinical trials of medical devices;

•       Experience in clinical trials in multiple disciplines;

•       Implementation of clinical trials in accordance with international standard operating procedures;

•       Implementation of quality control and quality assurance during clinical trials.

Range of services:

1.      Technical services for clinical trial protocol.

Establish clinical trial protocol according to product manual, product technical requirements, national and industry standards, review guidance and regulatory requirements;

2.      Selection of clinical trial facilities

Select qualified clinical institutions, communicate on the feasibility of the clinical trial, and determine the clinical trial protocol;

3.      Clinical monitoring service

Follow up ethics committee, clinical trial launch meeting and testing process, and promote testing progress and data quality;

4.      Clinical Data compilation and statistical report

Data entry, statistical analysis, formation of statistical report;

5.      Technical Services for clinical Summary Report

Preparation of clinical summary report in accordance with statistical report.