Integrated Summary of Safety – Complexities, Communication and Completion

1 minute read

Case Studies

Published: January 25th, 2021

Phastar was contracted to assist a pharmaceutical company with the conversion of 16 legacy studies to SDTM (2 SDTM “Like” phase II studies, 14 Legacy Phase I studies) and with the pooling and reporting activities of their Integrated Summary of Safety (ISS) for a regulatory submission. It has been quite a challenging project but one of the most exciting due to its complexity.

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