Let us handle the data so you can focus on running your program.
Quartesian’s data management processes are 21 CFR Part 11 compliant and user-friendly — ideal for paper CRFs, EDCbased projects, and rescue studies. We start by deploying a data capture system, then build the study database, review and verify data, and format it for submission to regulatory authorities — with database lock on or before deadline — every time. We are certified partners for multiple leading EDC platforms and offer CDISC expertise to help you maximize the value of your data.
KPS Life proudly partners with Quartesian to offer best-in-class Data Management and Biostatistical programming services. Our synergistic and seamless offerings enhance the quality of your clinical operations resources and allows you to better understand your data, resulting in true strategic control of your trial.
Data Management Planning
- Data management plan creation and maintenance
- Data entry guidelines/eCRF completion guideline creation and maintenance
- Site/CRA EDC training
- CRF/eCRF design
- Implementation of current data standards (SDTM, CDASH, and other CDISC standards)
- Customized clinical data management programming
- Data management consulting
Data Management Services
- Data entry and tracking
- Data conversion to proprietary data specifications
- Process and resolve queries
- CRF review and validation
- Third-party data integration
- Medical coding and serious adverse event (SAE) reconciliation
- Clinical trial rescue services
- Data development, testing, and deployment
- Database closeout and delivery
- Clinical database exports and interim analyses
- User access management
- Customized status reporting and data listings