Data Integration for ISS/ISE

Careful planning is necessary to integrate data from multiple clinical trials into an Integrated Summary of Safety (ISS) and Efficacy (ISE). The process of creating an ISS/ISE varies depending on the project, but Phastar has the expertise to effectively plan and manage the reporting work required for data integration. We customize the reporting of the ISS/ISE to meet the specific requirements of both the client and the regulators, ensuring that it is done in the most efficient way possible.

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 to integrate across studies and at what level

Only the study level data used in the production of the necessary ISS/ISE analysis are required to be included in the combined datasets

By consolidating data from multiple clinical trials, ISS/ISE provide a comprehensive and coherent view of a drug's safety and efficacy profile, elping to accelerate the drug development process, reduce costs, and improve patient outcomes. Contact us today to learn more.

Expert study design, statistical analysis, data science, data capture, and reporting for clinical trials