The growth of clinical trials in terms of scope and complexity is transforming the approach to content management in pharmaceutical, as well as biotechnology companies. Electronic Trial Master Files (TMFs) are, therefore, the go-to place for maintaining a central repository for the storage of clinical trial documents for use in regulatory submissions. With the next generation of eTMFs, more advanced technologies and capabilities will be rendered for sure.
Our client is a research-based global biopharmaceutical company headquartered in the USA. With an innovative approach and global resources, this company is engaged in the discovery, development, and manufacturing of healthcare products and vaccines. This involves extensive research, documentation, creation of case studies, and compilation of data in the form of images, documents, and other digital content management.
Our client uses eTMF – electronic trial master file for building these documentations for clinical trials. Celestial has been instrumental in the eTMF Next-gen project for our client, i.e., upgrading this eTMF application to use the latest production version of Ext JS 7.2.
The eTMF Next-gen project’s objective was to upgrade the eTMF application to use the latest production version of Ext JS 7.x and to re-architect the application so that it uses the inherent automated functions and features such Sencha CMD, MVVM, as well as proper theming. The existing eTMF application lacked the “Next Generation” TMF capabilities like automated quality checks, proactive monitoring, modeling, and predicting all aspects of records management from the study, design through closeout. We assisted in upgrading the older Ext JS version to the latest which follows the inherent automated functions and features such as Sencha CMD and MVVM.
The eTMF application was upgraded to the latest version of Ext JS with improvements in grid features, data binding, and even faster loading time
Re-architected the application to Model-view-viewmodel which resulted in a UI-based design system with improved application productivity, maintainability, flexibility, testability, and reusability.
The new app offered advanced functionalities such as automated quality checks, eliminating the need for manual QC findings, and providing alerts for low-performing studies and sites.
We used Model-view-viewmodel (MVVM) architecture for this eTMF Next gen project. The best part of MVVM architecture is that we can attach multiple views to a single viewmodel. A new Ext JS 7.2 classic app was created, and their existing code was copied into the correct folder structure of a MVVM Ext JS app. During the build, we created a single app under src/main/javascript, with Sencha app having its artifacts copied over to the appropriate subfolder under webapps. We had a Single Page Application (SPA) and each JSP was getting converted to a proper Ext JS Route and thus the URLs (deep linking) were almost identical.
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