On January 29, 2024, the 22nd communication meeting of the "Open Day of the Clinical Trial Institution Office" at the Sun Yat-sen University Cancer Center welcomed the R&D team from R&G PharmaStudies Co., Ltd. (hereinafter referred to as "R&G"). R&G is a contract research organization (CRO) specializing in providing comprehensive clinical research services for domestic and international innovative pharmaceutical and medical device companies, offering full-chain services for the pharmaceutical R&D process. Their services cover areas such as chemical drugs, biopharmaceuticals, vaccines, cell/gene therapy, medical devices, and traditional Chinese medicines and natural medicines. To date, R&G has served nearly a thousand pharmaceutical companies, helping numerous pharmaceutical and medical device products to adopt innovative designs and scientific methods, promoting efficient communication with the CDE and FDA, and accelerating the market approval of pharmaceutical and medical device products.
In the past two years, the Sun Yat-sen University Cancer Center and R&G have collaborated on more than 70 clinical research projects, over 50 SMO collaborations, and more than 20 ongoing CRO projects. Inevitably, various implementation quality issues arise in cooperation that require enhanced communication. Most of the sponsors served by R&G in recent years are Chinese innovative pharmaceutical companies, and there is considerable pressure on the team resources needed to be dispatched for quality management. However, R&G has always attached great importance to cooperation and communication with the Sun Yat-sen University Cancer Center and is full of expectations for this Open Day. They hope to learn through communication about aspects that need attention and improvement in daily monitoring, and hope to establish a closer cooperation model with the Sun Yat-sen University Cancer Center's Quality Management Team to jointly promote the smooth progress of clinical trials and provide sponsors with more reliable monitoring services.
Under the leadership of Senior Vice President Mr. Wang Tao, a delegation of seven representatives from R&G's Clinical Operations, Project Management, Project Quality Control, Site Management, and other departments participated in this exchange event. They engaged in full and friendly communication with the Sun Yat-sen University Cancer Center on the current state of their clinical trial collaboration, sharing of annual quality control issues in clinical trials, difficulties encountered in operational processes, system optimization, future cooperation between both parties, and other aspects. This laid a solid foundation for both parties to jointly promote the more efficient and high-quality conduct of clinical trials.
The participants of this Open Day event are as follows:
o Sun Yat-sen University Cancer Center:
Director Li Su, Deputy Director Cao Ye, Instructor Xu Ran, Head Nurse Ge Jieying, Instructor He Lianzhu, Instructor Guan Guangjun
o R&G:
Wang Tao, Senior Vice President; Yang Xiugeng, Vice President; Qiao Yuhang, Senior Director; Wei Yingyu, Operations Director; Zhang Caili, Operations Manager; Liu Shanshan, Project Manager; Liu Lin, Project Manager; Zhang Wei, Senior Quality Manager (online)
At the meeting, R&G's Senior Vice President Mr. Wang Tao first expressed sincere gratitude to the Sun Yat-sen University Cancer Center for arranging this communication meeting. Vice President Yang Xiugeng introduced R&G's development history, service scope, client profiles, project experience, project implementation, and the staffing situation of the Guangzhou office. Senior Director Qiao Yuhang shared the 2023 annual quality control results and raised discussions on specific operational issues involved in the collaboration, such as project initiation ethics, informed consent, original records, sample management, drug management, electronic medical record systems, and the application of broad consent.
