Data management and biostatistics

Data Management: Study Planning

 CRF development

 Patient diary development

 Development and testing of data base  

 Data Logistics (data flow, paper flow)

Data Management: Data Processing

 Customized database design (including development of description)

 Data entry  

 Remote data entry  

 Data validation (manual check, computerized edit checks, medical expertise)  

 Data coding in accordance to analysis plan  

 Data transfers in Client format

Biostatistics: Study Planning

 Statistical Plan development  

 Sample size calculation  

 Randomization code list generation

Biostatistics: Study Results Analysis

 Statistical analysis programs development (analysis programs, generation of Tables, Listings, Figures)

 Statistical analysis conducting

 Additional analysis for comparative, bioequivalence, crossover design studies

Biostatistics: Study Results Reporting

 Statistical interpretation of study results

 Study report writing (incl. second language report)

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