electronic trial master file (etmf)

Overview

Audit & Inspection readiness – The first and foremost aspect every pharma company / a CRO should consider is the Trial Master File (TMF) audit & inspection readiness. With stacks of essential electronic / paper-based clinical trial documents to be sourced, tracked and managed, the biggest setback companies could face is to allow reconstruction of the trial that confirms the quality of data produced. Therefore it is of paramount importance that these documents are filed, indexed, and archived in a way that they can be easily retrieved and available for inspectors to give insight about that trail. In addition to that, increasing complexity of clinical trials, procedural costs and redundancies with generation of essential documents may delay the approval of medicines to reach the market. This way, industry has come across a need for centralized eTMF solution which not only acts as centralized repository of all documents but also reduces costs included with paper TMFs significantly.

Freyr eTMF is a ready-to-use, audit-ready, secured, cloud-hosted, and pay-as-you-go solution that efficiently creates, exchanges, updates and manages complex and global clinical trial data across the lifecycle. The eTMF solution offers enterprise-class benefits in a cost-effective, on-demand suite to meet unique and demanding TMF needs of small-medium CROs as well as large Pharma companies.

electronic trial master file (etmf)

End-to-end TMF Process

Setup TMF Structure – Setup and Manage Doc Center – Monitor Compliance – Setup Audit Environment