Data center advantages:
Dimeisi, founded in 2003, is one of the first data statistics teams in China.
The data center consists of biometrics department, data management department and program department, undertaking projects at home and abroad and getting high public praise from customers.
At present, more than 80 employees are working from home and abroad. Nearly half of the employees have more than 5 years of industry experience while the core employees have more than 10 years of experience. It has more than 150 customers, with more than 1000 project completed.
A team of statistical experts from NMPA/FDA is available as technical support.
Extensive international and domestic IND/NDA trial data management and statistical analysis experience.
With the extensive CDISC experience, the company can provide statistical analysis and programming services that meet FDA requirements.
Building the Citrix-based centralized server platform over four years with high investment and state-of-the-art technology in the industry
International standard operating procedures and template libraries
Personnel stability, innovation-oriented, being evaluated as a study and research team by American customers for 3 consecutive years
Standardized training course library and perfect personnel training mechanism
Successfully entered the list of preferred suppliers for many domestic and foreign customers, and signed strategic cooperation agreements with many large domestic enterprises.
A customer’s only preferred statistical analysis service provider in China except for PAREXEL
Key member of the Secretariat and Training Department of the Data Analysis Professional Committee of the China Association for Medical Devices Industry
Data Center Service
Data management: Data management services for EDC projects and paper projects in each therapeutic area
Data management consulting and training
Case report form design
Database creation and testing
Data management plan development
Data verification plan development
Logic verification programming and testing
Double data entry and comparison
Manual verification & Medical verification
The generation and resolution of data doubts
Serious adverse event consistency check
Extrinsic source data processing
Master document management in data management
Progress report in data management
Blind data review
Data management report writing
Biostatistics: Provides comprehensive biostatistical services such as clinical trial design, analysis and reporting
Provide statistical support for communication between the sponsor and the administrative body
Clinical trial design and consultation
Statistical support for study protocols
Sample size calculation
Randomized protocol formulation and blind design
Develop statistical analysis plan
Develop statistical tables, figures, and listings templates
Statistical analysis report
Statistical support for clinical study report
Statistics support for registration application
Statistics Support for IDMC
Statistical programming: Provides comprehensive statistical programming related services, especially the implementation and electronic submission of CDISC
Generation and verification of analysis data set
Generation and verification of tables, figures and listings (TFLs)
CDISC implementation: Case Report Form (CRF) notes, SDTM, ADaM, Define files (PDF and XML versions), conversion of CDISC standards for historical data, etc.
Statistical programming for Integrated Summaries of Safety and Efficacy (ISS/ISE)
Interim analysis and statistical programming for Data Monitoring Committee