How To Close The "TMF Compliance Gap" With Advanced eTMF Archiving

By Aaron Grant

The TMF Compliance Gap occurs when your CRO uses their eTMF system to manage your study’s electronic Trial Master File. When the study is live, the eTMF is generally secure and inspectable in the CRO’s eTMF system - especially if they are using an advanced eTMF purpose-built for TMF management.

Once the study is closed, the CRO returns the eTMF to you for the reporting, assessment, and submission phase. Most eTMF systems are not designed or priced for longer-term inspectable storage, and CROs don’t want to be in the business of maintaining closed eTMFs. Your CRO will usually return the final eTMF in portable electronic formats such as DVDs or USB drives, cloud-based file folders, or even printed out on paper.

In this blog we dive deeper into the TMF compliance gap and a solution that encompasses software and expert services for inspectable and affordable eTMF storage can turn the industry-wide TMF Compliance Gap into a bridge that any organization can easily cross.