TFL Designer Case Study

• Manual shell creation across multiple studies and deliverables led to significant time consumption.
• Common safety outputs required redundant programming, resulting in inefficiencies and limited scalability.
• Ad-hoc requests were difficult to manage and often caused delays and workflow disruptions.
• Review cycles conducted via Word and Excel introduced version control issues and hindered collaboration.
• Updates and formatting changes had long turnaround times, affecting submission readiness.
• Existing processes lacked scalability to meet growing submission demands and evolving regulatory needs.

TFL Designer → SAS-based code generation with atlas → CDISC ARD & TFL output.

• Automated TFL creation using TFL Designer, eliminating manual shell preparation and reducing effort across studies.
• Rapid SAS code generation through atlas, ensuring faster and consistent programming for ISS submission outputs.
• Standardized CDISC-compliant outputs for seamless review and compliance, improving turnaround time significantly.

• The team created 223 shells in approximately 12 hours using TFL Designer templates.
• atlas automated the generation of 84% of TFL SAS programs from ARS metadata, reducing programming time by over 40%.
• Global changes (e.g., stat updates, additional treatment arm, precision) were applied across shells in minutes.
• Subgroup and custom outputs were created on demand , shells were added in seconds and programmed immediately.
• 21 reviewers collaborated directly in TFL Designer with built-in commenting, tagging, and version tracking.
• Fully aligned with CDISC ARS and ARD metadata models, enabling machine-readable, auditable outputs and future GenAI integration.