At the time of regulatory submissions, one of the most resource intensive and complex areas is getting the integrated summary of safety (ISS) and integrated summary of efficacy (ISE) ready. With several studies that have happened over a period of time and with multiple vendor partners supporting, the data can be diverse, complex, and hard to analyse.
Download this case study to read about one such complex project where Algorics was able to help a client with their ISS/ISE submission delivering over 600 tables, 50 listings and 15 figures, when the client data was highly inconsistent with diverse study designs and analysis.
As you plan for your ISS/ISE submission, reach out to our experts for a conversation on how the process can be made smarter and smoother. To schedule a meeting, write to us at hello@algorics.com