MANA RBM Products

Electronic Trial Master Files (eTMF)/Electronic Investigator Site Files (eISF)

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.