Renni's subsidiaries (Guangzhou Zhuyitong&Hunan Boshu) have received their second thank-you letter for the clinical trial project, following the first one from the adaptive hearing aid clinical trial project. This is the second thank-you letter received in six months. As a service organization, receiving a written thank-you letter from a customer is no different from the joy and sense of honor that a hospital feels when it receives a banner from a patient.
The client is a high-tech enterprise located in Dongguan City, specializing in the research and development, production, and sales of medical beauty equipment. The customer has an independent production park and has a very positive value system for product quality and business operations. At the beginning of the cooperation between the two parties, through talks, they determined that their values and beliefs were in line, and thus reached a cooperation agreement. This client was our first customer to sign a registration and clinical contract for radiofrequency therapy equipment, but due to their rigorous pursuit of product quality, it became the third project in terms of implementation sequence for radiofrequency skin therapy equipment. Internally, we refer to it as customer number 3.
During the implementation of client 3's project, several challenging and key points were identified, including the following:
1) Compatible with registration requirements in China, Europe, and America
Due to the client's expected markets being China, the European Union, and the United States. At the beginning of the clinical trial design, the differences in skin color between European, American, and Chinese populations were taken into account, as well as the cost factors of the enterprise. When conducting clinical trials in China, in addition to type III and IV skin, subgroups were specifically set up to include subjects with type I and type II skin tones. This kind of clinical cross-border compatibility design, which is one of the few in China, not only reflects our cost saving awareness for customers, but also demonstrates our courage to innovate and our ability to meet sufficient challenges.
2) Urgent enrollment requirements
Due to the relatively late start of the project and pressure from industry peers. Customer 3 is very urgent about the speed of joining the team, and the key is that this project also needs to include some sub group races (Type I and Type II skin colors). The pressure to enroll subgroups (type I and type II skin color) was entirely placed on clinical trial bases in first tier cities. In order to accelerate enrollment, we collaborated with professional recruitment companies, foreigner associations, and research centers to conduct recruitment across three cities: Shenzhen, Dongguan, and Guangzhou. Finally, with the strong cooperation of the research center, SMO company, and various parties, the enrollment of Chinese people was completed ahead of schedule (with a maximum of more than 20 cases enrolled in one day at a time), and the enrollment of subgroups (type I and type II skin color) was completed on schedule.
3) Stable research process
Based on the clinical trial experience accumulated from the radiofrequency skin therapy devices of customers 1 and 2, we have continuously optimized the clinical trial plan, improved SOP, cultivated the operation and implementation team, planned various contingency plans, and successfully completed the enrollment, implementation, and exit of the clinical trial with skilled clinical trial researchers and blind reviewers.
4) Good clinical quality
During the clinical trial, client 3 commissioned relevant parties to conduct a comprehensive inspection of the clinical trial process at two research centers. Due to our rich clinical practice experience and extensive GCP experience prior to this, our inspection has achieved relatively good results.
Based on the above main points, Customer 3 is very satisfied with the entire collaboration and clinical trial project. Of course, we were fortunate to receive a written thank-you letter from the customer unexpectedly. For service-oriented enterprises, this honor is a more generous and important reward and affirmation than economic rewards. Zhuyitong has several mature clinical trial experiences in radiofrequency skin therapy products, making it one of the most abundant clinical CROs in South China. At the same time, Zhuyitong has also conducted clinical trial projects on hair removal devices and subcutaneous fillers, gaining certain experience in the field of medical aesthetics.
In the future, Zhuyitong will continue to strengthen self-learning, accumulate project experience, improve project management, and steadily advance on the path of clinical trials, striving to do better and for a longer period of time......
