Beijing Tigermed-Jyton Co., LTD. ——Data Management and Statistical Analysis

Our DMSA team is data sensitive, has a strong study design background, and is good at DMSA of drugs and devices. We have a number of international statistical professionals. The team maintains a low turnover rate and high growth trend. Our senior statisticians have work experience of nearly 10 years in this field on average. We are expert in providing medical and statistical support for device submissions in the United States, Europe, China and other countries and regions, and have extensive experience with hundreds of projects. Our Aata team holds the following data management authorization certificates: 1. The only CRO company authorized by MediData Rave® in China 2. The first company in Asia which signed the CRO advantage projects with Oracle 3. Hold 10 Oracle certificates 4. Other certificates such as WHO-DD and MedDRA Our main data management systems include: 1. Oracle Clinical & Oracle Remote Data Capture 2. MediData Rave 3. InForm 4. ClinstReport 5. Clinflash Our main data management services include: 1. Data management consulting and training 2. Paper and EDC project 3. Case report form design 4. Build and validate database 5. Develop data management plan 6. Develop data validation plan 7. Edit check programming and testing 8. Double data entry and check 9. Electronization of data and manual review 10. Resolution of data queries 11. Medical coding 12. SAE reconciliation 13. Processing of external data 14. Database quality control 15. Blinded data review 16. Database lock 17. Data extraction and transfer 18. Preparation of data management report The range of biometric services we provide: 1. Offer comments to the Chinese Biostatistics Society as an expert, and participate in data standard setting, quality and biostatistics related projects of NMPA 2. Clinical trial design and consulting 3. Provide statistical support for the study protocol 4. Calculate the sample size / power 5. Randomizing design and coding 6. Develop statistical analysis plan 7. Prepare templates of statistical tables, figures and listings 8. Statistical programming 9. Generate data analysis set 10. Generate tables, figures and listings (TFLs) 11. Interim analysis and statistical support for the Data Monitoring Committee 12. Comprehensive summary and analysis of safety and efficacy 13. Statistical analysis report 14. Statistical support for the clinical study report 15. Statistical support for registration application 16. Statistical support for journals of various therapeutic fields, conference materials, posters and manuscripts