Customized Standards-Training Workshops

Description:  Mandated CDISC-compliance for a Government entities sponsored trials

Essex Role:

Provided standards training for CDISC alignment 

  • Prepare customized agendas, lessons plans, and training materials
  • Train study teams on CDASH,  SDTM, and ADaM for study build, reporting and analysis
  • Adapt existing organization-specific best practices to align CDISC conformance rules
  • Provide strategies to manage a CDISC aligned global library for reuse of standards

Results:

  • Aligned ~ 250 Government client standards with CDISC to support trial data submission to FDA
  • Eight Government client-funded research organizations successfully implemented CDISC standards
  • Decreased the need for data manipulation and transformation
  • Increased the quality of data and reduced data submission times
  • ~ 75% of Government client-sponsored trials activating after March 1, 2020 are CDISC compliant
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