Clinical Data Management

Data Management

Theradex offers a comprehensive array of data management services.  Our client-focused, expert staff has years of trial management experience in all phases of study build, conduct, and close-out activities.  We ensure the highest quality and integrity of data while accentuating a strong commitment to meeting all timelines and deliverables.  Our solutions-oriented approach to all endeavors and challenges ensures continuous operational excellence and client satisfaction.  Further, our patient-first approach to clinical trial management is an attribute that boldly distinguishes us from our competitors.  Below is a list of our key Data Management Services:

 

Document Development and Management

  • Data Management Plans (DMP)
  • eCRF Completion Guidelines (eCCGs)
  • EDC Design Specifications
  • Edit Check Specifications
  • Data Transfer Specifications
  • System Validation Specifications
  • Standards and Custom Listing Specifications

 

Electronic Data Capture Study Builds

  • eCRF Design
  • EDC Development and Validation
  • Edit Check Programming and Validation
  • Reporting Tool Configuration

 

Data Project Management

  • Data Cleaning
  • Medical Review
  • Quality Control Review
  • Medical Coding
  • SAE Reconciliation
  • Vendor Reconciliation