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