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
- System validation
- Project data management
Larix operates with a flexible approach to different data management systems. Depending on client wishes we can use different systems. Currently we support projects in the DM systems Trialmaster (from Omnicomm), Viedoc (from PCG group), and Rave (from Medidata). Before a new system is offered we perform all the necessary system validation steps to ensure that the system is fully 21CFR part 11 compliant and validated to all relevant standards. 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.