利用 Certara GlobalSubmit eCTD 软件，Prelude Therapeutics 将其质量控制 (QC) 流程从数小时缩短到了数分钟
2019年，一家小型癌症药物研发公司Prelude Therapeutics 采用了Certara GlobalSummit 递交管理软件，用于递交电子通用技术文档（eCTD）。Prelude Therapeutics 的监管团队非常精干，每年要负责30多份申报材料；因此，在发布、检查验证标准和审核 eCTD 方面需要达到最高效率。
The company found that their eCTD publishing process was not agile enough to meet their needs to implement updates quickly to submissions and provided limited reviewing capabilities through a third party. Without eCTD viewing software, they were unable to review the full scope of their submissions, hindering an effective review process. These challenges resulted in the decision to bring on GlobalSubmit eCTD software to make their regulatory submissions process more efficient.
Following the initial in-depth training provided by Certara, user acceptance testing (UAT) and validation, GlobalSubmit eCTD software was implemented into the regular review process. Hyperlinks and bookmarks are seamlessly created, and quality check (QC) is performed quickly and efficiently using the LINK and CROSSCHECK functionality in GlobalSubmit PUBLISH. With GlobalSubmit VALIDATE, more than 200 error conditions are checked, eliminating the risk of technical rejection. As a result, the QC process for each submission has been reduced from hours to minutes, saving their regulatory team considerable time.
For other stakeholders involved in the review process, GlobalSubmit WebReview provides a simple, easy-to-use interface to quickly search through applications and approve specific submission content. With GlobalSubmit eCTD software, the team appreciates that they can review the backbone of the regulatory submission, not just the folder structure, and that updates to eCTD requirements are automatically applied to the software and checked in real-time with live validation, eliminating the inefficiencies of finding technical issues. Since implementing GlobalSubmit eCTD software, Prelude Therapeutics has saved a considerable amount of time in their QC process and has become more efficient with their regulatory submissions.
