Are you planning a regulatory submission and need to include an Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) within your Common Technical Document (CTD)?
Due to the unique nature of each submission, understanding the best way to plan your integrated summaries 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.
Quanticate has long legacy of producing Integrated Summaries for a wide range of clients over the years. As a data-focused CRO, Quanticate has the programmers and statisticians to provide expert advice on the best way to combine data for an ISS/ISE, including help in identifying how ‘time to approval’ can be reduced by careful up-front planning.
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.
Within ISS, the safety results of different studies on the same compound are pooled together.
Within ISE, the efficacy results from different studies conducted on the same compound are combined.
Choose the best option that suits you and your trial.