Consistent Database Structure for Programs of Studies
Programs of Studies
Data Management
Database Structure
Need
- The client needed to run 3 healthy-normal trials at one Celerion clinic in addition to using two hospitals to run a hepatic and a renal study
Approach
- Utilized Celerion’s data management services for the 5 study program
- Experienced data managers designed Case Report Forms (CRFs) for the hospital data collection that was compatible with the electronic CRFs generated using Celerion’s proprietary ClinQuick® system
- Data programmers were able to utilize a consistent format for all 5 studies that followed the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) format
Benefits
- Celerion was able to deliver a quality, consistent database for all 5 studies, achieving the clients’s needed database lock timelines