ISS/ISE Package in Immunology

Metronomia successfully assisted a biopharmaceutical company in preparing an Integrated
Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) by integrating data from 11
heterogeneous clinical trials, of which five studies had legacy data formats. By standardizing data
formats, harmonizing endpoints, recoding medical terminology, and applying advanced statistical
methodologies, we delivered a comprehensive ISS/ISE package on schedule, ensuring a smooth
regulatory submission and strengthening our partnership with the sponsor.

This Case Study gives insights on

• Background
• Challenges and solutions
• Result