Client Associated Businesses, Inc.

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CLINICAL DATA MANAGEMENT

CAB offers a full range of Clinical Data Management services including:

 

STUDY START-UP PLANNING AND DEVELOPMENT

  • Project timeline development and maintenance
  • CRF development, based on protocol requirements
  • Data Management Plan component development
  • Project Notebook development and maintenance
  • Data validation document development
  • Self evident correction document development
  • Test, review and approve database and data entry screens
  • Test, review and approve validation procedures

 

DATA ENTRY, SCANNING AND INDEXING

  • Scanning and Indexing of paper CRF pages
  • Study Subject position data entry into Oracle Clinical™ database
  • First pass and second pass entry into Oracle Clinical™ and verification
  • Receipt, tracking and temporary storage of CRF pages
  • Data entry guideline development

 

STUDY CONDUCT

  • Discrepancy management in RDC studies
  • Data listing review for data cleaning and monitoring
  • Discrepancy resolution oversight/QC
  • Discrepancy review paper studies
  • Data Clarification Form (DCF) distribution
  • DCF resolution
  • Reporting using Oracle Discoverer™, Integrated Review, and Business Objects
  • External vendor data review and discrepancy processing
  • Lab data review

 

DATABASE LOCK AND VALIDATION

  • Database lock plan development
  • Quality control check of project database prior to database lock
  • Completion of database lock documentation
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