Quanticate has produced Integrated Summaries studies 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 ISS or 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 Integrated Summaries of Safety (ISS), we can pool the safety results of different studies on the same compound together. Advantages of an ISS include:
Within Integrated Summaries of Effectiveness (ISE) we combine the efficacy results from different studies conducted on the same compound. The increased advantages of ISE can:
Thanks again for taking the role for DMC unblinded programming. Your strong support made sure this first DMC was done well. Thank you again for successfully managing these deliverables on time. Very nice job!
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