Customize Your Clinical Study Protocol
Contact Customization
The core team and training system directly came from IQVIA, with shared global best practices, the complete training system (including SOPs, compliance, professional knowledge and core skills), the strict review standards, and abundant resources of global sites and investigator databases. The independent quality control department is established and supported by the shared IQVIA quality assurance (QA) system, aiming at providing an independent audit service and muti-layered quality protection.
Establish and continuously improve the complete SOP system in consistency with ICH-GCP, China GCP, regulations on medical devices and relevant laws and regulations in China. Perform risk management in full processes and ensure compliant and efficient clinical trial process and valid, reliable and complete data by customizing monitoring plan, active risk early-warning mechanism and multidimensional quality assessment.
Have a highly qualified core CRA team with low attrition rate and keep focusing on the China market.”
“Extensive experience and professional knowledge in complex therapeutic areas such as tumor, cardiovascular, endocrine and neuropsychiatric area.”
Kun Tuo team is equipped with a professional SSU team, paying exclusive attention to key points before initiation, such as protocol feasibility, site screening, submission for ethical purposes/OHGRA application and contract negotiation, so as to remarkably shorten the project initiation progress
“With the line manager taking responsibilities, the senior manager is in full charge of the recruitment, training, daily management and professional supports of CRA, guaranteeing a continuous high-level performance and ability of solving issues.”
Have established a wide and profound localized clinical study resource network, covering 28 major cities in China (such as Beijing, Shanghai and Guangzhou). Quickly response based on the project needs and provide qualified resources in many cities. Proficient with the characteristics and processes at various sites in China which increases the operation efficiency and decreases the costs and risks of the development.”
