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- High quality
All of our core quality training programs are complete Chinese versions based on Quintiles training and evaluation systems. Training covers SOPs, business compliance training, clinical research knowledge, working skills and core competences. Kun Tuo shares information with Quintiles concerning sites and investigator databases. Assisted by Kun Tuo’s own quality management and quality assurance support, we also receive independent auditing from the Quintiles QA department.
- Fully developed SOP system
Our SOP systems comply with ICH-GCP, China GCP, Medical Device & Diagnostic (MDD) regulations and relevant legal and regulatory requirements.
- Robust clinical operation management and experienced team
Our stable, highly qualified professional team is focused on local clinical research in China and has built up a significant body of experience in all major therapeutic areas including oncology, cardiovascular, endocrinology and psychiatry. Experienced CRA line managers are responsible for CRA recruitment, daily management, training and operational support in order to deliver high quality clinical service.
- An extensive, highly efficient local network of research resources
We have established extensive local networks of research resources to promote continuous improvement in operational efficiency and reduction in R&D costs. We provide clinical monitoring services in Beijing, Shanghai, Guangzhou, Hangzhou, Nanjing, Shenyang, Changchun, Shijiazhuang, Tianjin, Changsha, Wuhan, Chengdu, Chongqing, Xi’an, Jinan, Kunming, Nanning, Fuzhou, Suzhou and other major urban centers. We are also positioned to rapidly provide qualified clinical research resources at any time in more cities in response to your project needs.
Our clinical monitoring services
- Verifying site certification, conducting protocol feasibility investigations and questionnaire surveys
- Conducting site screening, EC submission, host investigator meeting and study initialization
- Routine monitoring and closing visits according to study protocol and work scope as well as SOP and GCP requirements
- Clinical monitoring for various indications in Phase I-IV clinical studies
- Monitoring for non-interventional observational clinical studies
- Clinical monitoring for Medical Device & Diagnostic (MDD) trials