Clinical Trials – Statistical Programming

Project image

Business Goals

  • The customer's goal was to modernize their data processes to meet CDISC standards, enhance data transformation, and enable data-driven decision-making in clinical trials.

Challenge

  • Our customer, involved in clinical trials, grappled with the challenge of ensuring CDISC standardisation, efficient data transformation, and advanced statistical analysis.

Results

  • SDTM annotated CRF development and QC (raw data -> SDTM)
  • SDTM Development (SDTM -> ADAM) - 13 weeks
    • SDTM worflow specification development
    • SDTM domains development
    • SDTM QC
  • ADAM Development (ADAM -> TLF) -> tables, lists, figures
    • Study-level ADAM data programming
    • Study-level ADAM data quality control

Implementation Details

  • 13 SDTM
  • 10 ADAM
  • 14 Tables
  • Presented results, 3rd phase confirmed

Industry

Service

Type

  • Template Solution

Keywords

  • AI Software Development
Roadmap
SDTM annotated CRF development and QC
SDTM Development (SDTM -> ADAM)
ADAM Development (ADAM -> TLF) -> tables, lists, figures

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    Michael Gurbych Director,
    Operations and Finance
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    Roadmap
    SDTM annotated CRF development and QC
    SDTM Development (SDTM -> ADAM)
    ADAM Development (ADAM -> TLF) -> tables, lists, figures