Integrated Summaries of Efficacy and Safety (ISE/ISS)

Your expert partner for a successful and timely FDA and EMA submission

Work with our experts to put together your ISE/ISS package and successfully defend it in front of authorities. Benefit from our team’s decades of experience in navigating the complexity of ISE/ISS.

We help you answer the key questions for successful ISE/ISS submission:

  • Which data should you submit and in which format?
  • How will each study contribute to the evaluation of the benefit / risk?
  • Which subpopulation should you investigate?

Comprehensive Guide to the Content of Integrated Summaries of Efficacy and Safety (ISE/ISS)

Access this comprehensive guide to ISE/ISS content to understand what the summaries must include and the requirements for the successful electronic submission of clinical data. The guide shares what to consider when submitting to FDA and EMA.

We offer the full range of
ISE/ISS support:

  • Clarification of how each study will be used in the ISE/ISS
  • Programming, validation, documentation of SDTM and ADaM pooled datasets
  • Strategic statistical support to write the integrated Analysis Plan, including definition of sub-populations and grouping of trials
  • Coding harmonization to the latest WHODrug and MedDRA dictionary versions
  • Gap analysis to evaluate availability and CDISC compliance of study data to be included in integrated analyses or submitted in eCTD Module 5
  • Conversion of legacy data into CDISC
  • Writing of the Study Data Standardization Plan (SDSP) as required for pre-NDA discussions with the FDA
  • Statistical analysis, including reconciliation with the clinical study reports
  • Defending integrated Analysis Plan and SDSP during Type C or pre-NDA meetings with FDA or scientific advice meetings with EMA
  • Expert medical writing services and statistical support for the development of eCTD Module 2 and 5

Why partner with us for your ISE/ISS?

  • Our experts have supported sponsors by defining and defending statistical strategies in 100+ meetings with FDA and EMA.
  • We currently deliver six ISE/ISS per year for electronic submissions for marketing approval.
  • Our submissions are 100% on time and have a 100% technical review acceptance rate with the FDA.
  • We have decades of experience in defining and defending mapping and standardization strategy as part of implementing a CDISC submission package.
  • We are your one-stop-shop for the complete eCTD common technical document. Our team includes biometrics experts alongside regulatory, medical writing, and medical strategy experts.
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