Case Study 2 - Clinical Data Management Optimization


Challenge:

  • Huge recruitment and data management effort (recruit 600,000 subjects at 200,000 subjects/year for 3 years for Diabetes      Registry, 3 page CRF/subject)
  • Monthly development, safety update report required (provide up-to-date summary tables/listings/figures safety profile)


Solution:

  • Utilized ten full-time experienced Data Coordinators and many well-trained part-time Data Coordinators
  • Built massive database for capturing and cleaning almost 2 million CRF pages!
  • Established effective communications between field CRAs/CRCs and Data Managers
  • Validated SAS Macro system to expedite the delivery of monthly development safety update reports


Results:

  • Reduced Data Management  preparation timelines from 4 weeks to 2 weeks
  • Increased productivity and reduced costs from change-orders
  • Recruited all 600,000 patients in record time!