Case Study 2 - Clinical Data Management Optimization
- 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)
- 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
- 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!