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.
rockacola 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.
|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）