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    EXPERTISE

    Integrated Summaries of Safety & Efficacy (ISS ISE) Services

    Ensure a successful regulatory submission when drawing conclusions from multiple studies.

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    Partner with the leading niche Biostatistics CRO

    At Quanticate, our biostatisticians have a desire for quality and implement the best approach to a client situation/scenario to ensure correct analysis without an over complex process. By using the appropriate tools, we are able to demonstrate the efficacy of a drug and present the results in the clearest way possible.

    Biostatistics is necessary for all investigational drug or device development programmes to determine the efficacy and effectiveness in clinical trials. This includes the study designs, study conduct, determining the most effective data collection points and how analysis and reporting should be performed.

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    Our ISS ISE Services

    Our ISS ISE services support you with the analyses of data from more than one study by pooling subject-level data or pooling common outcomes from individual studies and comparing results. We will help you demonstrate evidence of effectiveness across different sub-groups such as demographic characteristics such as sex, age and racial sub-groups and other relevant sub-populations like patients with different levels of severity of disease. This includes the strength of statistical evidence from the consistency of the findings across individual studies especially for pre-specified primary endpoints.Any important differences in outcome need to be discussed and displayed and if possible, factors underlying the differences be identified. Quanticate are able to use our statistical tools to help identify inconsistencies across studies and underlying factors associated with these differences. We will describe key statistical issues and findings that impact the demonstration of efficacy and/or safety based on each study and on the collective evidence.

    SE and ISS Statistical Analysis Plan

    Strategy for Pooling Data including Dataset Specifications

    Combined ADaM datasets

    Analyses, summary outputs and figures by subgroups and sub-populations

    Statistical Analysis Plan for Comparison of Individual Studies

    Unanticipated study conditions, such as site-related differences in standard care identified if possible

    Report written for inclusion into Module 5 of CTD

    Assessment of data and analysis quality

    Evaluation of efficacy

    Review of study design, endpoints, and statistical methodologies used

    Assessment of the generalizability of the results from review of Sub-groups, sub-populations and differences between studies

    Recommendations for further analyses to address concerns and issues

    OUR SPECIALIST GUIDANCE

    Integrated Summaries in Your Common Technical Document (CTD)

    Due to the unique nature of each regulatory submission, understanding the best way to plan your integrated summaries to include an Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) within your Common Technical Document (CTD) can be difficult. Challenges arise when combining multiple studies to review the safety and efficacy of an IND/NDA. Standardization across data is mandatory as regulatory bodies seek CDISC standards within your submission. 

    An ISS or ISE are both important tools - as the 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. After combining data for an ISS/ISE, support in the ISS/ISE preparation within the CTD can be provided by our medical writing department. 

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    Integrated Summary of Safety (ISS)

    Within ISS, the safety results of different studies on the same compound are pooled together.

    The 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

    Integrated Summary of Efficacy (ISE)

    Within ISE, the efficacy results from different studies conducted on the same compound are combined.

    The advantages of ISE include:
    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

    Resources to ensure you have a successful regulatory submission when drawing conclusions from multiple studies

    A Guide to Integrated Summaries of Safety & Effectiveness (ISS & ISE)

    A Guide to Integrated Summaries of Safety & Effectiveness (ISS & ISE)

    This guide demonstrates how to plan, review, produce successful integrated summaries of safety and effectiveness (ISS & ISE) for regulatory submissions
    Learn more
    Integrated Summaries (ISS/ISE)

    Integrated Summaries (ISS/ISE)

    Quanticate outlines the issues that can arise in the planning of an Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
    Learn more
    Integrated Summaries for an Orphan Drug

    Integrated Summaries for an Orphan Drug

    This case study considers the production of an ISS and ISE for an orphan drug.
    Learn more

    We are here to help you navigate complex regulatory submissions.

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