Clinical Data Management

Palm Beach CRO offers a full range of Data Management services to successfully collect, process and analyze results of your clinical trials. We provide high-quality and extensive data management support for both paper-based and Electronic Data Capture (EDC) platforms.

Clinical Data Management Services are 21 CFR Part 11 Compliant and includes:

  • Data Management Trial Master File (TMF) Set-up and Maintenance
  • Development of Data Management Plan (DMP)
  • Development of Case Report Form (CRF)/ Electronic CRF (eCRF)
  • Subject Diary Design and Development
  • Development of CRF/eCRF Completion Guidelines
  • Database Design and Validation
  • Database Development Specifications (CDISC Compliant)
  • Data Validation Manual (DVM) Development
  • Development of Data Transfer Specifications
  • Generation of Edit Check Specifications, Validation and Testing
  • EDC System Training for Sites and Monitors
  • IVRS/IWRS Randomization and Inventory Management
  • Consultation in Selecting ePRO Vendors
  • 24/7 EDC Helpdesk
  • Data Transfers & Integration
  • Discrepancy Management and Data Cleaning
  • MedDRA and WHODrug Coding
  • SAE Reconciliation
  • Final Study Archival