Overview

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 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
 

Freyr eTMF Expertise

  • Freyr eTMF is designed using the best practices as defined by industry experts
  • Supports the DIA TMF reference model version 3.0 for both core and recommended documents
  • Using a host of built-in innovative features (metadata recognition, duplicate reduction, and auto indexation), Freyr eTMF uniquely standardizes various clinical documents and related processes
  • Significantly reduces document processing times and improves productivity by standardization of the entire trail master file process
  • A unique on-demand cloud-based architecture allows the clinical trial managers and remote site trial staff to access the system anytime, anywhere with customizable access levels
  • Intuitive and simple user interface allowing internal and external staff to collaborate and contribute content virtually
  • Robust, customizable and real-time reporting features with comprehensive reports for each milestone
  • Easily configurable to client’s existing TMF index
 

Freyr eTMF Features

Flexible and Customized

  • Light weight system with excellent performance levels
  • One stop doc center to view and manage user access based overview with secure user roles
  • Dashboard providing documents overview and comprehensive status
  • Category and functional-line based doc groups to easily manage various clinical trial documents
  • Advanced search functionality based on document title or any meta data
  • Flexible and customized folder management
  • Advanced admin functions to manage users and monitor activity
  • Bulk upload and assigned capability on clinical trial documents
  • Validation-ready IQ/OQ documentation
  • Fully meets the 21 CFR Part 11 compliance standards
  • Meets ISO 9001 quality and process standards
  • Meets ISO 27001 information security standards

Covers End-to-end TMF Process

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

Cloud Advantage

  • Subscription-based model enabling organizations to focus on business than on infrastructure
  • State-of-the-art workplace & disaster recovery and optimized business continuity plans (BCPs)
  • Secure SAS 70 certified cloud 1A data center
  • Hosted and operated at the largest workplace recovery facility in East Coast, US
  • Better access to the tool from anywhere: Secure cloud-hosted application offering real-time authoring, reviewing and approval
  • Unique on-demand and highly scalable cloud architecture with global access functionality
  • Global repository of clinical trial documents
  • Significant cost savings

To Know More about Freyr eTMF and to take a feature-specific comprehensive product tour.

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TMF Consulting Services

Freyr Service

With a fully configurable clinical trial document management software and  best-of-breed Regulatory professionals monitoring eTMF compliance updates, Freyr offers companies the best of both worlds – on-demand eTMF software solution as well as a Centre of Excellence (CoE) that offers best in class, cost-effective and customizable eTMF supporting services model built around clients’ unique and demanding requirements.

Click on below tab to know more about TMF Consulting Services CoE.

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