Integrated Summaries of Safety and Efficacy (ISS/ISE) are an analysis of results that determine the safety and effectiveness of drugs in development, including rare adverse events.

CROS NT can support your Integrated Summaries project with the following services:

  • Expert project management with quality deliverable KPIs
  • Regulatory consultancy on EMA and FDA submission requirements
  • Statistical Analysis Plan with an analysis of aggregated data and methodology
  • Programming macros and pooled datasets in CDISC format
  • Expert Medical Writing services

Several study programs conducted by CROS NT have included the preparation of ISS/ISE for both the EMA and FDA. We know what problems to anticipate when working with distributed data and we have an excellent track record in overcoming obstacles. We have integrated large numbers of studies, providing data mapping, warehousing, analysis, visualization and medical writing services.

Market Leader in On-Time Preparation and Submission

100% on-time submission rate for ISS/ISE

Expert project teams of Statisticians, Programmers, Data Managers, Medical Writers and Project Managers

EMA and FDA Regulatory Strategy support
(EMA SME qualified company)

CDISC compliant datasets and mapping of legacy data