ISS ISE Services

Quanticate has produced Integrated Summaries for various clients over the years. As a data-focused CRO, Quanticate has the programmers and statisticians who can provide expert advice on combining of data for an Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE), including help in identifying how time to approval can be reduced by careful up-front planning. An ISS or ISE can be an important tool as a larger sample size of data allows for easier identification of any correlations and trends. This allows for better-presented and unbiased data for regulatory submissions as the regulatory authorities state ISE and ISS are critical components of a submission. Support in ISS/ISE preparation can be provided by our medical writing department.

Within ISS, we can pool the safety results of different studies on the same compound together. Advantages of an ISS include:

  • Identification of common related adverse events (AEs)
  • Identification of common serious adverse events (SAEs)
  • Identification of safety concerns that may not be apparent from a single study
  • Allowing an assessment of safety in subgroups if sample sizes are sufficiently large

Within ISE we combine the efficacy results from different studies conducted on the same compound. The increased advantages of ISE can:

  • Enable the assessment of efficacy in subgroups (e.g. paediatrics)
  • Enable the assessment of the efficacy of secondary endpoints, which may have been under-powered in individual studies
  • Allow detailed comparison of results versus a comparator drug
  • Allow assessment of the efficacy of repeat doses
  • Enable the dose-response profile to be more accurately estimated
  • Allow any changes that may have occurred in efficacy over the lifetime of the drug development to be investigated
  • Help to address why results for a particular study may be inconsistent with the results of other studies
  • Enable the assessment of the sensitivity of results to different methodologies for defining endpoints, or different methodologies for handling missing data

Integrated Summaries

ISS ISE Role of the Medical Writer  

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