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

Trainings

• IBM EDC Training for Primary Investigators