Our data management teams will work with you to provide high-quality data that will meet the needs of your clinical trials and regulatory agencies.
Our data services include development of case report forms and translation of raw case report data to electronic media with double-entry verification and edit check processing. QST can also provide conversions of client databases and full electronic data capture systems.
Data is routinely received and transmitted electronically. These data may be source data, programs, or word processing files containing the statistical reports for incorporation into the client's submission. Responsibility for overseeing the databases of more than 170 clinical studies manifests our experience in database architecture, programming and clinical data management.
QST specializes in Phase II and Phase III clinical studies, but can provide data management services and query process for all clinical studies.
Data Management Services
- Case report form and electronic case report form design
- Database design and validation
- Electronic data recognition
- Double data entry (data entry and validation)
- Edit check specifications development, programming, QC programming, validation, processing and resolving
- CRF tracking and query tracking
- 3rd pass QC system including independent QC database
- Full service design and setup of electronic data capture [EDC] systems including trial manager functions, eCRF design, EDC edit check specifications, system testing, data review and cleaning, variable annotation, export file specifications and export file QC
- Medical dictionary coding (MedDRA, WHODrug dictionaries)
- External data integration and processing (e.g., laboratory data, ECG data)
- Data cleaning
- Database lock procedures
- Compilation of paper CRFs, laboratory reports, data clarification forms (DCFs) into PDF documents including bookmarking