An Introduction to Integrated Summaries of Safety & Effectiveness [Video]

Integrated Summaries of Safety (ISS) and Effectiveness (ISE) are essential for drug and device approvals, combining results from multiple trials into one clear narrative. In this video, we’ll show how they help spot rare side effects, prove treatments work across different patient groups, and speed up the review process, all while covering key steps like merging data cleanly, following industry data standards, and running thorough quality checks.

At Quanticate, our teams of biostatisticians, programmers, and medical writers specialise in producing integrated summaries that meet global regulatory standards. From early Phase II planning and SAP development to data mapping, pooled analyses, and mock review plans, we can support you every step of the way to ensure a successful submission and product launch. Submit an RFI today.