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· Data management, data analysis, documentation and reporting in compliance with current ICH/GCP guidelines |
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· Extensive set of SOPs implemented
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Data Management
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· CRF design and printing |
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| · Database development | |||
| · Data management plans | |||
| · Data entry: independent double data entry and verification by file comparison and proof reading against the CRF | |||
| · Coding of text data according to industry standard coding systems | |||
| · Data validation: customized programmed checks for completeness, accurateness, plausibility and consistency of clinical data according to a data validation plan; generation and tracking of queries | |||
| · Audit trail to document all changes in the database | |||
Biometrics |
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| · Statistical consulting | |||
| · Statistical analysis plans | |||
| · Sample size estimation and power calculation | |||
| · Randomization | |||
| · Pharmacokinetic analysis. | |||
| · Statistical evaluation (clinical studies, data overviews,
meta-analyses) |
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| · Presentation of analysis results supported by comprehensive tables, figures and data listings | |||
| · SAS software used for statistical analysis | |||
