Clinical Operations

The Clinical Operations Department of R&G was established in 2008 and was one of the earliest departments established by the R&G Group. The total number of staff is about 500, including about 100 people of project management team composed of project directors, project managers and quality personnel, and more than 400 well-trained clinical research associates and clinical trial assistants, basically covering all cities and regions involved in clinical trials nationwide, in which all middle and senior managers and more than half of project managers have working experience in foreign-funded pharmaceutical enterprises and foreign-funded CROs. The Clinical Operations Department of R&G has managed more than 500 phase 1 to 4 clinical trials in the past, covering almost all therapeutic fields, especially oncology, cardiovascular, endocrinology, psychosis/neuropathy, respiration and other fields. We have accumulated rich experience in clinical trials of innovative drugs, especially in the field of oncology to establish our core competitiveness.

We also have a specialized start-up team and a HGRAC team, which are sufficient to ensure that R&G can quickly start the project, enroll and submit high-quality clinical trial data, greatly saving time and reducing R&D costs for customers. Our clinical operations team maintains a good cooperation relationship with hundreds of clinical trial institutions certified by the NMPA and PI and KOL experts in various therapeutic fields, and can efficiently and quickly communicate with the institutions for the sponsor. It has incomparable professional advantages and speed in terms of site and investigator screening, ethical submission, contract signing, etc.

At R&G, we believe that service is as important as quality. The Clinical Operations Department has a comprehensive ICH standard SOP and training system, and a four-level quality control system to ensure high quality implementation of clinical trials. The Clinical Operations Department has successfully passed the system and center audit of dozens of domestic and foreign customers, and successfully passed verification by the CFDI, NMPA on more than 60 projects. The success rate of the projects applied by R&G up to now is 100%, providing a strong guarantee for the successful marketing of the products.

Services include:

Regulatory project management, early project management, international project management, post-marketing project management;

Clinical monitoring, quality control training, clinical trial platform management, various audit services