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Analysis & performance
 
Products & Solutions

Data Management and Biostatistics

We support clinical and nonclinical activities as a boutique CRO in the fields of diabetes, metabolic research and dermatology by providing tailored data management and statistical services.

Services

Data Management

  • Development of Data Management Plan
  • CRF / eCRF Design and Validation
  • Electronic Data Capture (EDC)
  • User Account Management and EDC Training
  • Development of Validated Data Interfaces for external various data sources (e.g. saftety lab, PK, PD, Sensor data)
  • Medical Coding (MedDRA, ATC/DDD)
  • Data Validation Plan (incl. edit checks, rules)
  • Data Cleaning according to DVP incl. query management
  • Data Visualization
  • Data Base Release Meeting
  • Data Conversion and Export (CDISC SDTM, define.xml, CDISC SEND)
  • Database Lock
  • Data Transfer
  • Data Archiving
Services

Biostatistics

  • Protocol development support
  • Sample size calculation
  • Statistical Analysis Plan (SAP) development including specifications for tables/listings/figures (TLFs)
  • Support in the randomization set-up
  • Data screening including outlier treatment and data imputations
  • Interim analyses
  • Statistical programming with SAS®
  • Validation of all SAS-scripts including double programming
  • Statistical reports
  • ADaM and define.xml
  • Transfer of analysis data
  • Support in the interpretation of statistical results
  • Archiving
  • Customized plots and analyses for publications