4 - Case Studies
Integrated Summary of Safety – Complexities, Communication and Completion
January 25th, 2021 • 1 minute read
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 […]