The industry has focused primarily on data to implement Risk Based Monitoring (RBM) and total quality management; documents including informed consents, represent a critical component for compliance and quality oversight. While developing a complete remote trial management approach, MANA RBM created a basic system that can be deployed with ShareFile. We have also worked with TransPerfect to implement our proven eISF approach in its Trial Interactive software.
MANA RBM’s eTMF/eISF solution includes specifications, work instructions including instructions for generating certified electronic copies, and customizable archives to support separating subject source documents from the Sponsor’s eTMF. We offer consulting to help you set up and manage your eISF/eTMF internally or we can manage if for you.
MANA RBM has partnered with Transperfect to delivery an automated integrated eTMF, eISF, and learning management system for larger, more complex trials. This approach allows us to automate document and training management. It also allows us to do efficient risk-based oversight. We can also provide all missing documents--whether start up or subject specific source documents--to save hours of time managing your documents. For more information or support in implementing document management into your RBM strategy, contact us.