AI-Powered Next-Gen TFL Automation for a Top 3 Pharma Company

Situation

  1. A top 3 pharma company had a strategic imperative to utilize AI to drive business value.
  2. They entrusted us with this initiative, based on our proven track record in delivering quality, speed, and innovation.
  3. Manual TFL coding is slow, resource-heavy and prone to errors, creating scalability and compliance risks.
  4. R adoption remains limited due to steep learning curves and fragmented workflows, driving up cost and delays.

Task

  1. Deliver value beyond the AI imperative by translating automation into measurable gains in speed, quality and compliance.
  2. Seamless integration of AI tools within established statistical workflows and cross-platform flexibility (SAS, R, Python).
  3. Accelerate programmer adoption while ensuring audit-ready accuracy and regulatory confidence
  4. Build scalable solutions to support future portfolio needs

Action

  1. Delivered specialized training on prompt engineering and GenAI use cases
  2. Developed modular templates optimized for reporting
  3. Blended AI with QC for reliable outputs
  4. Predefined AI prompts for faster TFLs
  5. Established process and  governance for compliant AI programming
  6. Enabled scalable frameworks adaptable across studies and sponsors

Result

  1. ≥50% productivity boost with significant cost savings
  2. Faster, compliant and audit-ready submissions
  3. Reusable modules that scale across studies
  4. Realigned senior programmers to focus on complex & high-value analyses
  5. Increased sponsor confidence with transparent & explainable AI outputs

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