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服务介绍

      Clinical trial is one of the most important link in the registration process of medical devices. Some medical devices must be verified the safety and effectiveness through the specific implementation of clinical trials. The whole process is systematic and professional, with a long cycle and high cost.

      Tacro has built professional teams in medical/audit/data management/statistics field, more than 55% members have master's or doctor's degree. We have a number of clinical experiences in high-risk, difficult medical equipment, such as: semiconductor laser therapy equipment, artificial heart axial flow pump, hemodialysis equipment, absorbable orthopedic internal fixator, immune quality control, gene sequencing equipment, ultrasonic diagnostic equipment, medical software, etc.

      Has cooperated with more than 180 national drug clinical trial institutions in Beijing, Shanghai, Zhejiang, Hubei and other places. At the same time, we keep following up the laws and regulations, doing project management and quality control based on the professional design of clinical trials so as to help clients take a key step.

服务内容
Clinical Service Clinical trial Clinical trial protocol design, draft and review
Clinical trial institute investigation and confirmation
Clinical trial launching
ethical review, clinical trial filing, contract signing, initial meeting
Getting approval from China Human Genetic Resources Administration Office
Clinical trial monitoring 
Clinical trial audit
Clinical trial data management
Clinical trial statistical analyse
Clinical trial report draft, review, modifying
Clinical evaluation Comparing products with the same variety
Comparison and explanation of clinical trial exemption products
only for products in the Clinical Exemption Catalogue