Electronic Trial Master Files

Equipped with DIA TMF Reference Model and the KHP-CTO Investigator Site File Review Checklist, our eTMF system classifies, stores, manages and maintains all trial master files in a central “location” where access is full controlled. User can create a folder, drag/drop files, search, review, comment files, and setup access restrictions in the system. The system can display the status (“missing”, “ongoing”, “final”) at folder or file level. At the time of trial closeout, the system will pack the eTMF for regulatory submission or archive.