Changsha Duxact Biotech Co., Ltd.
Changsha Duxact Biotech Co., Ltd. (abbreviated as Duxact) was established in 2016. It is a high-tech company integrating production, learning, and research, providing one-stop services for global clinical research on drugs and medical devices. The company is headquartered in Changsha High-Tech Industrial Development Zone, Hunan, with more than 700 employees and an office and laboratory area of about 8,000 m2.
Based on the company’s strategy, Changsha Linkmeds Co., Ltd. (SMO service), Changsha Phamark Data Technology Co., Ltd. (data management & statistical analysis), Changsha Tonoinfo Technology Co., Ltd. (information platform construction), Changsha Duxact Clinical Laboratory Co., Ltd. (biomarker testing, precision medicine), Changsha Centen Intelligent Technology Co., Ltd. (subject recruitment) were successively established.
One-stop clinical research service
Sample analysis and testing
Data management & statistical analysis
Medical affairs service
Consultation concerning GCP filing
IT-based Medical R&D construction
Intelligent laboratory platform (ILP)
Pharmaceutical Research Laboratory Information Management System (PharmLIMS)
Laboratory Information Management System for Drug Metabolism and Pharmacokinetics (PharmLIMS for DMPK)
Intelligent Biobank Management System (BioBank)
Electronic Lab Notebook (PharmELN)
Intelligent clinical platform (ICP)
Ethical review cloud platform (YooTrial ETHICS)
Phase I data management system (YooTrial Capture)
Clinical trial project management system (YooTrial CTMS)
Subject intelligent authentication management system (YooTrial Auth)
Electronic data collection system (YooTrial EDC)
Biomarker testing and individualized medication consultation
Early warning: Prediction of cardiovascular disease risk and adverse drug reaction
Diagnosis: Auxiliary diagnosis of rare diseases, detection of pathogenic microorganisms, auxiliary diagnosis of diabetes
Individualized treatment: Individualized treatment of tumors, individualized administration for cardiovascular diseases
Monitoring of drugs and foreign matters in the body
Established therapeutic window in China: Blood drug concentration monitoring
Established international therapeutic window: Establish a therapeutic window for the Chinese population to carry out blood drug concentration monitoring
Non-established international therapeutic window: Establish a therapeutic window to carry out blood drug concentration monitoring
Research and quality analysis of TCM genome
DNA barcode identification of TCM
Quality marker testing of TCM
Detection of heavy metal residues in TCM
Detection of pesticide residues in TCM
◆Efficient one-stop service
The one-stop service platform ensures the seamless connection and efficient operation of clinical research projects at all stages. The average project speed is 30% ahead of the industry. The previous bioequivalence (BE) research projects can be completed within 90 days at the fastest from sampling to application dossier submission.
◆ Strong professional strength
The core technical team has more than 30 years of experience in innovative drug Phase I-III studies and generic drug BE research. Moreover, the company has hired more than 50 first-line experts and scholars to form an academic committee to provide intellectual support for the company's innovative research and development.
◆ Rich project experience
A total of more than 700 clinical research projects have been carried out. Among them, more than 60 have been approved for production and more than 500 have been completed. The average incurred sample reanalysis (ISR) is 99% (international standard > 67%). We have experience of more than 70 on-site inspections by national and provincial bureaus, with a pass rate of 100%, and experience in efficient and mature drug review and communication.
◆ Accurate and efficient recruitment
The self-developed YooTrial Auth system can intelligently query and identify volunteer information to ensure that the data is true and accurate. It has also jointly established a volunteer database with Taimei Technology and Guangdong, Hong Kong and Macao, which currently covers more than 200 domestic institutions and has information on more than 500,000 volunteers.
◆ Sufficient clinical resources
Cooperate with/co-build 60+ clinical research centers, all of which meet GCP/ICH-GCP requirements, and work closely with more than 200 clinical experts in multiple fields and domestic core principal investigators (PIs). The project can be flexibly arranged for ethical review meetings and scheduling to fully guarantee the quality and efficiency of clinical trials.
◆ Excellent analytical capability
The Analytical Testing Center has developed 500+ pharmaceutical bioanalytical testing methods. The laboratory complies with ISO/IEC 17025, CFDA GLP, and CMA standards. It is the only drug metabolism and pharmacokinetics (DMPK) joint laboratory with Waters in the world, with an average daily testing quantity of 300+ per single instrument. It has passed the national external quality assessment with full marks for 4 consecutive years.
◆ Internationalized data analysis
By international standard data management & statistical analysis software, coding dictionaries: SAS, PASS, WinNonlin, MedDRA, WHODRUG, EDC (Medidata Rave, CIMS, Taimei, Clinflash EDC, etc.), the project is submitted in accordance with CDISC standards. We also have an international pharmacovigilance team, which meets the needs of international and domestic project cooperation.