Congratulations! You Just Acquired A Trial Master File. Now What?

In an industry filled with mergers and acquisitions (M&As), obtaining responsibility for an existing Trial Master File (TMF) is not uncommon. It can be extremely challenging to transition responsibility smoothly, however, particularly with an active TMF or one from an older study.  

Following are common issues Phlexglobal’s TMF experts encounter with an acquired Trial Master File: 

• No workable index 
• Missing, inconsistent, and corrupted content 
• Mix of paper and electronic documents 
• Multiple file formats for the electronic files, such as PDFs, ZIP files, and annotation attachments 
• Incomplete audit logs 

• Key essential documents in local languages that have not been translated 

Thoughtful planning while considering what regulatory authorities will want to see in your TMF will help to reduce issues and ensure inspection-readiness of the Trial Master File for an acquired product or study.