Integrated Summary of Safety – Complexities, Communication and Completion

1 minute read

Case Studies

Published: January 25th, 2021

Phastar was contracted to assist a pharmaceutical company with the conversion of 16 legacy studies to SDTM (2 SDTM “Like” phase II studies, 14 Legacy Phase I studies) and with the pooling and reporting activities of their Integrated Summary of Safety (ISS) for a regulatory submission. It has been quite a challenging project but one of the most exciting due to its complexity.

Complete the form below to read the full case study

Related articles

Efficient Project Management for a Late-Stage Parkinson’s Disease Study 
Case Studies

Efficient Project Management for a Late-Stage Parkinson’s Disease Study 

January 6th, 2026 1 minute read

Phastar partnered with a biotechnology sponsor to manage statistical and data management activities for a late-stage ...

Turning Legacy Complexity into Submission-Ready Confidence
Case Studies

Turning Legacy Complexity into Submission-Ready Confidence

November 24th, 2025 1 minute read

Discover how Phastar converted 16 legacy studies into SDTM and delivered a robust Integrated Summary of Safety (ISS) ...

Delivering a Complex Integrated Summary of Effectiveness: Efficient Pooling and Advanced Analysis Across Four Multiple Sclerosis Spasticity Studies 
Case Studies

Delivering a Complex Integrated Summary of Effectiveness: Efficient Pooling and Advanced Analysis Across Four Multiple Sclerosis Spasticity Studies 

November 17th, 2025 1 minute read

A sponsor needed to pool data from four MS spasticity studies—one still ongoing with another vendor—while adapting mi...