Part 1: Introduction With the country join ICH and the rapid improvement of clinical research related laws and regulations, regulatory authorities have put forward new requirements for the quality management of drug clinical trials, and pharmacovigilance has also faced in new challenges. In order to implement the “Drug Administration Law of the People’s Republic of China”, standardize pharmacovigilance during clinical …
On April 8, 2021, Toripalimab injection(recombinant humanized anti-PD-1 monoclonal antibody injection, JS001) is used to treat locally advanced or metastatic bladder urothelium after failure of standard treatment Cancer (UC) indications were officially approved by NMPA. Meta Clinical Technology Co. Ltd., undertook the data management service of this study, and cooperated with Junshi and contributed to the application and approval of …
Under the leadership of the clinical operation center of CSC, and the joint efforts of the CRAs in the conference affairs team. CSC held the first on-line investigator meeting during Covid-19. From the development of <CRA Work Guidelines> and <Intention to Participate in Research>, then to inviting various site departments and institutions to participate in the meeting, from confirmation of …
Clinical Service Center Co., Ltd. is honored to invite Dr. Yan Bo (Ph.D, MBA) to join Meta Clinical Technology as the Senior Vice President of Biostatistics and Statistical Programming Department. Dr. Yan Bo graduated from the University of Illinois at Chicago with a doctorate and a master’s degree in statistics. He has more than 26 years of biostatistics experience in …
There’s a revolution taking place in China’s healthcare sector, and it has nothing to do with COVID-19. Despite all the reports you may have seen suggesting that new medical infrastructure in the country was being developed in response to the emergence of the new coronavirus, this is something that was in motion long before, and it’s set to change millions …