Clinical Data Management Services

Our CDM team will help you focus on the key variables that directly drive safety and efficacy analysis. We have closed hundreds of databases and our experience means you get the quality data outputs you need.

Start-Up Services

  • Protocol and Protocol Amendment Review
  • Creation of Core Documents (Data Management Plan, Data Quality Plan, Communication Plan, Study Timelines, eCRF Guidelines, etc.)
  • Global Library Development or Integration
  • eCRF Development
  • Edit Check / Logic Check Creation
  • IWRS/IVRS Set-up
  • User Acceptance Testing (EDC system)
  • External Vendor Set-up (Central / Local Labs, Imaging, ECG, etc.)
  • SAE Reconciliation Plan

Study Conduct Services

  • Query Management and Data Review
  • Medical Data Review
  • Data Listing Creation and Review
  • Study Metric Reports (Outstanding Queries, Missing Pages, Expected Pages, etc.)
  • SAE Reconciliation
  • CDM Project Management
  • Mid-study Database Changes
  • Data Tranfers
  • Interim Analysis Cleaning and Data Transfer