From data capture to storage we can handle large studies fully compliant with existing rules and regulations. Auxiliis uses EXPERT (former eDM) software for data capture and data management.
EXPERT is an Oracle based clinical data management system that provides a comprehensive solution for collecting, cleaning and managing clinical trial data in any development environment – from single site to worldwide operations.
The current implementation assures a high speed, high capacity and scaleable IT infrastructure that is sized to meet both current and projected data volumes for all clinical trials. With the aid of these ’end-to-end’ solutions we are able to accelerate your products’ time to market while ensuring superior quality and cost containment.
EXPERT is a fully validated, 21 CFR 11 compliant and FDA approved data management system.
Our services:
- CRF design and construction,
- Build study databases, including screen design,
- Double data entry (two teams working independently) or electronic data capture,
- Identify data quality problems by visual-, range- and consistency checks,
- Integration of central laboratory results into database,
- Medical monitoring, including medical review of study data,
- Reconciliation of SAE reports with CRF data,
- Coding of adverse events/medications/diseases (using various dictionaries, e.g. sponsor-provided),
- Data validation with complete audit trailing,
- Quality control of the database versus the CRF.