Data Management and Statistical Analysis

Release time:2018-11-27 Source of the article:Data Management and Statistical Analysis

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
Medical coding
Serious adverse event consistency check
Extrinsic source data processing
Master document management in data management
Progress report in data management
Blind data review
Database lock
Data transmission
Data management report writing
Biostatistics: Provides comprehensive biostatistical services covering clinical trial design, analysis and reporting
Provide statistical support for communication between sponsors and regulatory bodies
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 sheet, tables and 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.
Electronic submission
Statistical programming for Integrated Summaries of Safety and Efficacy (ISS/ISE)
Interim analysis and statistical programming for Data Monitoring Committee

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