Protocol Design: Includes clinical trial protocols, informed consent forms, investigator's brochure, Case Report Forms (CRF), trial summary, and summary reports, etc.

Clinical Monitoring: Includes site screening, SMO (Site Management Organization) screening, ethical communication, genetic office assistance, routine monitoring, institutional agreement signing, etc.

Data Management: Involves CRF collection and sorting, data auditing, database construction, data management reports, etc.

Biostatistics: Covers sample size calculation, randomization and blinding design, statistical table design, SAS programming, meta-analysis, data statistical reports, etc.

We are capable of undertaking clinical trials for Class II, Class III, and innovative medical devices, including active implantable, passive implantable, in vitro diagnostic (IVD) devices, and other types of medical equipment.

Our clinical trial team has undergone rigorous GCP and SOP training and participated in numerous registration clinical trials for innovative medical devices, IVD products, and pharmaceuticals.

The Clinical Trial Department is currently establishing clinical CRO and SMO technical teams across multiple regions in China. It has also formed cooperative relationships with institutions such as the Teaching and Research Office of Statistics at Nanjing Medical University and Peking University Health Science Center. This enables us to provide full-service capabilities from project initiation, protocol design, site screening, quality control to report writing, ensuring high-quality clinical data support for registration applications.

Equipped with complete simulated wards and operating rooms, we can conduct usability tests on medical devices intended for registration at various levels.

We collaborate with local medical schools such as Guizhou Medical University and Zunyi Medical University, along with standardized training bases for resident physicians, to carry out basic clinical skills training and assessments in simulated environments.

Together with qualified clinical trial institutions, we regularly offer GCP training for doctors, technicians, CRAs, CRCs, corporate research, and other medical-related personnel involved in clinical trials.

In conjunction with clinical studies initiated by clinicians, we jointly complete relevant clinical research work.

For more information about our services or to tailor specific solutions, please contact our professional team.