Data Management Services

Clinquest offers full data management capabilities either in support of our clinical trials or as a service in support of clinical trials run by other organizations. Our department is conversant with regulatory FDA and European regulatory requirements.

 

Data Management Services:

  • Data Management Planning
  • CRF design, completion instructions, printing management and distribution
  • CRF annotation
  • Data Validation Planning
  • Database structure Set-up
  • Program and validate the data validation checks and loading process
  • CRF and DCF tracking
  • Independent double data entry and discrepancy resolution
  • Concomitant drug (WHO Drug Dictionary) Coding
  • Adverse event, diagnoses and indication (MedDRA) Coding
  • Automated validation checks and manual CRF review
  • Data Clarification Forms generation and resolution
  • Data transfers
  • Status reporting
  • SAE reconciliation, CRF to database QC
  • Database lock and Data Management Report