Clinical Data Management

The Quanticate Clinical Data Mangement team will design your CRF, build the database, implement edit checks, and handle all discrepancy management. We code adverse events, medications and medical history, and produce data summaries for review. We can also arrange for CRF translation and/or printing and their subsequent distribution to the sponsor or direct to the investigators.

As part of our Clinical Data Management services we can offer our customers 24-hr secure access to reports on the status of their ongoing studies (for both paper and EDC studies). Quanticate provides a standard set of reports in addition to custom-designed reports.

We have extensive experience in helping our customers become CDISC compliant, and have undertaken numerous projects involving the migration of legacy data to CDISC standards.

Typical data management activities include:

  • CRF Design
  • CRF Distribution
  • Data Management Plan
  • Database Design
  • Translations / Scanning
  • Double Data Entry
  • CRF Tracking
  • Status Reports
  • Data Imports
  • Laboratory Data Management
  • Manual and eValidation Checks
  • Query Generation and Resolution
  • Medical Coding
  • Reconciliation of SAEs
  • Data QA / QC
  • Interim Analysis Datasets
  • Database Lock
  • Export of SAS Datasets