Healthcare
Clinical Trials – Statistical Programming
Statistical programming for phase 2 clinical trials of anti-skin disease drug candidate.
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
Alex Gurbych
Chief Solutions Architect
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