eTMF Management, eTMF software, electronic Trial Master File

Audit & Inspection readiness - The first and foremost aspect every Pharma company / a Contract Research Organization (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 software 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 life cycle. 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.

End-to-end TMF Process

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

• Simple setup and configuration of your TMF structure and defining document groups, users and report templates

• Simple setup of the doc center

• Easily and quickly configure document lifecycle admin function to create and index documents as per the TMF structure

• Effortlessly perform bulk document grouping, indexing and virtual folder management & storage

• Efficiently manage document workflow process

• Re-use and share without duplication across – reviews, approvals, versions, search, distribution, publishing, export and archival

• Easily enable collaboration, data sharing & updates across diverse global Regulatory functions

• Monitor compliance and metrics as well as create and export customized reports for real-time reporting and distribution

• Easily create an audit environment, assign users and support internal and external audits