CLINICAL TRIAL
Protocol Design
Trial protocol, informed consent form, investigator's brochure, CRF, trial summary, summary report, etc.
Clinical Monitoring
Site screening, SMO screening, ethical communication, genetic office assistance, routine monitoring, institutional agreement, etc.
Data Management
CRF collection and sorting, data audit, database construction, data management report, etc.
Bio-statistics
Sample calculation, randomization and blinding, statistical table design, SAS programming, meta-analysis, data statistical report, etc.
Class II, Class III and innovative medical devices that need to undergo clinical trials, including clinical trials of active, passive, implantable, IVD and other devices.
The Clinical Trial Team have received strict GCP and SOP training, and participated in many clinical trials of innovative medical devices, IVD devices and drugs for registration.
Conduct the Pre-clinical Animal Study in Guiyang Phase II Large Animal Test Center based on the regulatory requirements.
The Clinical Trial Department is simultaneously building the clinical CRO and SMO technical teams in various sites across China, and establishing a cooperative relationship with the Teaching and Research Office of Statistics of Nanjing Medical University and Peking University Health Science Center. Therefore, it has the ability to provide full-process services for clinical trials from project initiation, protocol design, site screening, quality control to reporting, and provide clinical data assurance for registration.
Have complete simulated wards, operating rooms, etc., conduct different levels of Usability Tests on medical devices to be registered.
Cooperate with local medical schools (Guizhou Medical University and Zunyi Medical University) and the standardized training bases for resident physicians to conduct basic clinical skills training and assessment in simulated wards, operating rooms, etc.
Cooperate with qualified clinical trial institutions to provide regular GCP training for physicians, technicians, CRAs, CRCs, corporate research and medical-related personnel involved in clinical trials.
Jointly complete relevant animal tests or clinical studies in combination with the clinical studies initiated by clinicians.