Overview
A global leading biotech conducting multiple Phase I oncology trials across the U.S. and EU was under pressure to streamline CDISC-compliant analysis deliverables ahead of submission deadlines.
01
The Challenge
- Despite a modern SAS-based ecosystem, the client's statistical programming team was bogged down in manual scripting to generate Analysis Results Datasets (ARDs) using CDISC Analysis Results Standards (ARS).
- With each study spanning hundreds of outputs, ARD traceability to source and TFLs was a time sink, delaying timelines and QC bandwidth.
02
The Solution
- To eliminate redundancy and bring reproducibility into focus, the client adopted siera, Clymb's automation solution built entirely in R.
- Within weeks, they overhauled their ARD generation process using metadata as the blueprint.
03
The Conclusion
- By automating the generation of CDISC-compliant ARDs, siera drastically improved efficiency in statistical programming.
- The acceleration streamlined clinical reporting timelines and allowed the team to focus on analysis strategy and submission readiness with confidence.
- This led to faster database lock-to-submission cycles without compromising quality or traceability.
- Achieved a 60% reduction in ARD programming per study, significantly accelerating the turnaround of TFLs and statistical reports.
Outcomes
- Eliminated hand-coded ARDs
- Enables earlier data insights
- Full TFL compatibility
- Ensured regulatory compliance with CDISC
- Seamless collaboration with cross-functional teams
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