In the fast-evolving biopharmaceutical industry, accelerating regulatory submissions is crucial for ensuring timely access to life-saving medications.

This webinar will explore how a metadata-driven approach can expedite statistical review and streamline programming — from SDTM mapping to report generation. Our experts will introduce Cytel’s innovative automation tools, designed to transform submission workflows by improving quality, consistency, and speed.

Discover real-world applications and key benefits to optimize your regulatory submission strategy. Don’t miss this opportunity to gain valuable insights and stay ahead in regulatory compliance!

 Key Topics

• The role of metadata in automating SDTM and ADaM mapping
• Leveraging automation tools for streamlined TLF generation
• Reducing manual interventions while maintaining data accuracy

Speakers

• Manish Deole, Principal Statistical Programmer
• Sebastià Barcelo, Associate Director Statistical Programming