Tribute to the third anniversary | Duxact team: Linkmeds
Source:DUZHENG Release date:2019-03-06
On the platform of Duxact, Linkmeds is
responsible for the subject recruitment – the first link.
However, this team’s energy goes well beyond this.
The Team Tribute Series on the Third Anniversary Celebration of Duxact
takes you into “Linkmeds.”
Duxact established Changsha Linkmeds Co., Ltd. (hereinafter referred to as “Linkmeds”) in 2016, which is committed to providing innovative clinical research technology services integrating clinical trial subject recruitment and clinical research center site management (SMO).
Since its establishment, adhering to the purpose of innovation and seeking truth, the team has provided better technical services for customers, tried its best to help customers shorten the time of drug R&D and reduce the cost of R&D, and facilitated the development of national pharmaceutical industry.
Core business I: Clinical research center site management service (Site Management Organization, SMO for short)
The SMO business covers more than 20 provinces in China. Linkmeds has provided more than 100 CRC technical services for domestic and foreign pharmaceutical enterprises. As a supplier, it has participated in more than 40 clinical research projects submitted to CFDA, and accepted CFDA on-site verification for more than 20 times, with a passing rate of 100%.
Core business II: Clinical trial subject recruitment
“Hemujia,” an Internet platform subordinated to Changsha Linkmeds Co., Ltd., is the first professional institution that provides clinical trial subject recruitment service in Central China. So far, it has served more than 60 domestic and foreign pharmaceutical enterprises, and carried out nearly 200 clinical trials as scheduled. Through the Internet+ recruitment mode, “Hemujia” has laid out thousands of grassroots medical units across the country, formed a network of linkage between medical institutions and complementation of clinical research information, and solved the difficulties in recruiting and managing clinical trial subjects.
We successfully completed the subject recruitment and site management of the clinical research center in a “Bioequivalence Study of Clozapine Tablets in Human Body” from August to December 2018.
Clozapine is a drug used for the treatment of schizophrenia. The subjects to be recruited in this study were schizophrenics, most of which seemed lack of capacity for civil competence. If they are required to participate in a clinical study, investigators have to acquire not only these subjects’ informed consent, but also the consent of their legal guardians, as well as a signed written document before entering the study.
Unfortunately, those patients may have defensive or aggressive behaviors at the time of onset, as well as symptoms of excitement, irritability, depression and anxiety. This may greatly increase the difficulty of site management.
Within three months after the trial was launched, the recruiters visited more than 20 community hospitals and more than 10 psychiatric specialist hospitals in Hunan province and overcame problems such as special types of subjects, fewer sources of disease, and difficult site management. More than 300 schizophrenic patients and their legal guardians were visited and they agreed to participate in this study. They assisted the study center in completing the screening. Finally, 42 subjects were successfully enrolled.
During the month-long study cycle, CRC colleagues were not afraid of poor compliance and difficult management from those psychiatric patients; strictly complied with the requirements of GCP and clinical trial protocols; assisted researchers in completing data, documentation and subject management with high standards; and completed the research center site management with a high quality.
Address: Lugu Science and Technology Industrial Park C10, 28 Lutian Road, Changsha High-tech Zone, Hunan
Contact person: Chen Weiming 15173178871
Zip code: 410205