Phastar supported a sponsor in delivering a high-quality Integrated Summary of Safety (ISS) for a rare disease program in aPAP, pooling three studies into multiple analysis datasets and generating 84 outputs.
Our team tackled ongoing data updates, structural variability, complex safety derivations, and FDA change requests, ensuring alignment across all outputs and regulatory readiness.
Advanced statistical programming for AESIs, SMQs, and ECG analyses
Agile integration of evolving datasets
Clear, proactive communication with the sponsor
Outcome:
A submission-ready ISS delivered on time, with strong sponsor recognition for precision and responsiveness.
Read the full case study to see how Phastar manages complex ISS projects with efficiency and accuracy.
