We provide a full set of data management services, ranging from defining the information to be collected to exporting data for statistical analysis, focussing on the essential of each project. We work to minimize the timing between the processes of data collection and data analysis, with a high standard of quality, always complying with the specificities of your goals.
Our data managers are members of the Society for Clinical Data Management (SCDM) and of the Clinical Data Interchange Standards Consortium (CDISC).
Our processes follow the good clinical data management practices from start to end.
Our Data Management services
- Clinical Study Protocol (support in data definition and data handling procedures)
- Case Report Form (CRF/eCRF) development and design
- Data Management Plan
- Database development and implementation
- Database support documentation (annotated CRF, datasets specification/dictionary, data entry instructions manual)
- Data Validation Plan
- Data entry (single/double; local/hybrid/remote)
- Data validation
- Discrepancy management
- External data management (e.g. laboratory data)
- Data coding according to MedDRA dictionary and WHO ATC/DDD classification
- Quality Control
- Database lock
- Data transfer
- Data Management Report
- Data Export
- Applying CDISC standards (CDASH)
- Preparation of submissions to regulatory authorities (EMA and/or USFDA)