Integrated Summary of Safety (ISS) and Efficacy (ISE)

Integration of data from a number of clinical trials for an Integrated Summary of Safety (ISS) and Efficacy (ISE) requires careful planning.

Every ISS/ISE is different, and PHASTAR has the experience to plan and manage the reporting work for data integration in ISS/ISE.

We tailor the ISS/ISE reporting to meet both the client and the regulator requirements in the most efficient manner.

PHASTAR’s expertise includes:

  • Assessing the analysis and reporting requirements for the ISS/ISE
    • Develop a clear understanding of what questions the ISS/ISE is trying to answer and how these requirements differ to those already answered by the individual studies
  • Analysing requirements against pre-existing study level analysis
    • To be considered sufficient, outputs from individual studies need to be able to provide a complete response to the regulatory questions without the need for the reader to combine tables
  • Determining what data types should be integrated across studies and at what level (SDTM/ADaM) the integration should occur
    • Only the study level data used in the production of the necessary ISS/ISE analysis are required to be included in the combined datasets.

Get in touch to see how PHASTAR’s expertise can help your data integration for ISS/ISE.

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