Data Management
Our Department of Data Management (DM) offers many years of extensive experience in data management and we can provide expert services in all key areas of the data management process e.g.:
- Input to trial protocols
- Data management plan
- (Electronic) case report form ((e)CRF) design
- Database design
- Validation plan and validation checks
- Data Entry
- Query process
- Coding (adverse events, diseases and medications)
- Database release and transfer of data using SDTM format
- Data management report
- Support interim analyses, data reviews and DMC
Our DM services are based on the eDM system from the US company OmniComm. The system is fully 21CFR part 11 compliant and validated to all relevant standards, can handle paper CRFs as well as data capture (eCRFs) and has a portal where information can be shared with sponsor. We also offer working with sponsor’s own data management system, e.g. Oracle Clinical.
Data Management also supports interim analyses, data reviews and data monitoring committees (DMC). Data are delivered in the “Study Data Tabulation Model Submission” (SDTM) format, according to the CDISC specifications.
