VCRO (Shanghai) was established in China, Shanghai, in 2020 by Virginia Contract Research Organization Co., Ltd., and has become a qualified supplier of one of the top five pharmaceutical companies in China in the same year, cooperating with a number of Chinese pharmaceutical companies for Sino-US double reporting. VCRO has also attained more than 50 US FDA IND achievements, including new chemical drugs, botanicals, biologics, and 505b2 drugs in the United States declaration achievements, clinical trials involving blood tumors, infections, central nervous system, cardiovascular system, gastrointestinal system and other fields, approval rate more than 95%.
VCRO (Shanghai) is committed to providing customers with a full range of medical technology services in China, the United States, Europe and some Asia-Pacific regions to declare drugs and medical devices. VCRO (Shanghai) leverages the expertise and resources accumulated by its parent company in the field of international clinical research to provide comprehensive services to Chinese customers, covering clinical trial design, data management, statistical analysis, regulatory affairs and quality assurance. Through these professional services, Chinese customers can more easily access the international market and promote the global rollout of their innovative medicines. VCRO (Shanghai) provide a customer-centric, one-stop service, combined with VCRO Group’s expertise in China, the United States, Europe and some Asia-Pacific regional regulations, committed to design the best clinical development strategy, to provide customers with no time difference, no cultural and language differences, local Chinese and American double report service, simplify the process and improve communication efficiency. VCRO’s medical, registration, clinical data team is composed of senior director (more than 15 years of service in Victoria company) experts, and the company’s senior practitioners are stable and ranked first in the industry.
For Chinese sponsors’ overseas registration clinical strategies, VCRO can provide more optimized solutions, including
Overseas production layout of cell therapy products and registration clinical and other convenient ways
To solve the differences in clinical trial data caused by racial differences in products
China’s cell-based products departure control
Further accelerate the development of Chinese products overseas
Good at communicating with regulatory authorities
For many times, the product used by the human body for the first time can be directly entered into Phase I and II, or even directly into Phase II and III
Excellent overseas clinical operations team to facilitate sponsors to conduct clinical trials overseas
Perform hospital screening of clinical trials, clinical trial PI assessment, application for ethics approval, etc. All can fully comply with local regulations and quality requirements.
Development capabilities for cutting-edge products
VCRO specializes in working with startups to move from clinical to human trials, especially in the development of cutting-edge products
As early as 2018, VCRO successfully applied for the approval of the cell therapy product FDA IND.Especially how to connect directly submitted to the FDA IND declare CDE project
Extensive overseas development capabilities
VCRO is one of the few registered clinical programs in the United States and Europe to have an in-House team
Assist Chinese customers to internationalize products as quickly as possible
VCRO has been investing in the field of cell therapy for more than 20 years, and has accumulated nearly 40 cell therapy commissions covering immune cell and stem cell products in a wide range of medical fields, such as cancer, orthopedics, hepatobiliary gastroenterology, ophthalmology, dermatology, etc.We provide our clients with complete services from early stage product development strategy layout, regulatory approach, pre-clinical and product CMC process consulting, to clinical trial protocol design, Pre IND consulting meetings, IND document preparation and submission, and clinical trial execution.Through our rich practical experience, with you hand in hand to achieve the ultimate goal.