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Manual shell creation across multiple studies and deliverables led to significant time consumption.
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Common safety outputs required redundant programming, resulting in inefficiencies and limited scalability.
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Ad-hoc requests were difficult to manage and often caused delays and workflow disruptions.
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Review cycles conducted via Word and Excel introduced version control issues and hindered collaboration.
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Updates and formatting changes had long turnaround times, affecting submission readiness.
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Existing processes lacked scalability to meet growing submission demands and evolving regulatory needs.
TFL Designer
SAS Based Code Generation
CDISC ARD & TFL Output
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Automated TFL Creation using TFL Designer, eliminating manual shell preparation and reducing effort across studies.
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Rapid SAS Code Generation through ATLAS, ensuring faster and consistent programming for ISS submission outputs.
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Standardized CDISC-Compliant Outputs for seamless review and compliance, improving turnaround time significantly.
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The team created 223 shells in approximately 12 hours using TFI Designer templates.
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atlas automated the generation of 84% of TFL SAS programs from ARS metadata, reducing programming time by over 40%
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Global changes (e.g., stat updates, additional treatment arm, precision) were applied across shells in minutes.
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Subgroup and custom outputs were created on demand. shells were added in seconds and programmed immediately.
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21 reviewers collaborated directly in TFL Designer with built-in commenting, tagging, and version tracking
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Fully aligned with CDISC ARS and ARD metadata models, enabling machine-readable, auditable outputs and future Gen-Al integration
Outcomes & Impact
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90% reduction in time to develop shells
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40% time savings in programming through automated code generation
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Streamlined collaboration with centralized review and approval
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Rapid turnaround for study additions, treatment group changes, and ad-hoc requests
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Scalable and reusable metadata framework for future submissions
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