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. safety 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