Data Management

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, design, implementation and management of electronic data capture (EDC) systems, edit check processing, data review and cleaning, adverse event and medication coding, and database lock processing.

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 600 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.

EDC System Certification for Design and Build
  • Medidata Rave®
  • Medrio eClinical
  • Merge eClinicalOS™
Data Management Services
  • Full service design and setup of 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
  • EDC System Validation
  • Electronic data recognition
  • Vendor data reconciliation including programming and validation of edit checks external to EDC system (e.g., laboratory data, ECG data)
  • Medical dictionary coding (MedDRA, WHODrug dictionaries)
  • Data cleaning
  • Database lock procedures
  • Compilation of electronic casebooks including bookmarking