Prelude Therapeutics 社は、サターラの GlobalSubmit eCTD ソフトウェアを用いて承認申請の品質管理（QC）プロセスを数時間から数分へと短縮
In 2019, Prelude Therapeutics, a small cancer drug discovery company, implemented Certara’s GlobalSubmit submissions management software for their electronic common technical document (eCTD) submissions. The regulatory team at Prelude Therapeutics is very lean and responsible for more than 30 submissions annually; therefore, the utmost efficiency in publishing, checking the validation criteria, and reviewing eCTDs is required.
“For a small team that has limited time to compile and double check a submission, GlobalSubmit is a really good platform because it is all integrated, including CROSSCHECK and VALIDATE. So, you know when you generate the submission that it is compliant, and you don’t need another tool for validation”