Service scope

服務范圍

Bioequivalence test (BE)
Generic drug consistency evaluation
Innovative drug Ⅰ - Ⅳ period clinical research
Clinical study on medical devices and biological products
Professional medical services

專業的醫學服務

Both the nori and Deus medical teams are all medicine education and professional background, and the industry experience covers important diseases such as tumor, respiration, digestion, endocrine, cardiovascular and cerebrovascular diseases. Has now set up perfect the SOP system and quality control process, to provide customers with professional BE clinical trials and Ⅰ ~ Ⅳ writing services (research plan, informed consent, summary report, etc.) and medical inspection services, provide a scientific and comprehensive clinical trials for the whole medical service.
Efficient clinical operation

高效的臨床運營

Clinical operations currently focus on innovation and the German America medicine phase I clinical trials, generic consistency evaluation and bioequivalence study, has the rich clinical experience in project management, hospital good relations of cooperation. Have a sound quality management and quality control system to ensure that the project process conforms to the requirements of ich-gcp and China GCP, and can obtain high-quality clinical data.
Perfect quality assurance system

完善的質量保證體系

With german-american special clinical quality assurance department is responsible for the project from start to finish the whole process of quality control, including the review of project information at various stages, receives the recipients of the process of examination of test samples, the review of the process of project data archiving, the professionalism of the systematic process of technical training to implement the control are implemented strict management in an all-round way.
Abundant base resources: new construction and long-term stable cooperation base
Abundant base resources

豐富的基地資源

Building base:
As of the end of 2017, noand demei will be involved in the joint construction of 5 bases, including:
Agency data preparation, clinical test area and the ward of the layout and design, related software and hardware facilities equipped, team construction, SOP writing, GCP training, experiment of speaking skills training, medical training, the training of the laws and regulations, the current five bases have been carried out preliminary experiments.
Stable cooperation base:
Cooperate with and german-american clinical trial base resources are mainly distributed in Beijing, tianjin, jilin, shanxi, shandong, jiangsu, yunnan, anhui and other places, by the end of 2017 stable cooperation base for a total of 30. With complete SOP and implementation, the equipment and management of hardware and software are in accordance with the requirements of test and regulations. These cooperative bases are characterized by rich experience in team testing, good compliance with the test process, strong ability of PI and rigorous test.
Professional data management and statistics

專業的數據管理與統計

1. Team members have rich experience in clinical trial projects
2. Work strictly according to industry regulations
3. Use EDC system for data management
4. Use SQL and SAS to list complex query data for easy verification
5. Adopt the Winnonlin7.0 software to form PK analysis report on PK data analysis
6. A dozen years of clinical trial statistics analysts strictly control the statistical analysis
Good expert resources

良好的專家資源

The company has maintained good communication channels and interactive relations with CFDA and CDE, and closely followed up the projects in the review, so as to keep abreast of the progress of the review; At the same time the company also specially invited Beijing university institute of clinical pharmacology, national drug and metabolic product analysis research center within the institutions such as a number of experts as the company's technical adviser, regular reading and discussion with the company policies and regulations, not to the company on a regular basis to carry out the project for technical guidance, and the preliminary verification to the final project filing materials, help to control the risk in the process of project implementation, ensure project quality and efficiency.