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.

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 Capabilities

  • 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.

Request a Demo
 

Successfully Built up Centralized eTMF System

Freyr successfully built up centralized eTMF tool based on client requirements and configuration that resulted in significant cost savings. Download

TMF Consulting Services

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 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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CLIENT TESTIMONIALS

 
  • During the past several years, I’ve had the pleasure of working with Freyr in the publication, validation and electronic submission of regulatory documentation to the US FDA. The Freyr team has provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.

    President,
    An Independent regulatory and quality consulting company

  • Freyr was a great find indeed. The Freyr Publishing team catered excellent Study Report publishing services. The icing on the cake was their proper coordination, flexibility, dedicated study team, timely and constant communication and subject matter expertise that added to the ease of doing business and towards successfully accomplishing the end goal. This, as well as the fair pricing, is what sets Freyr apart from their competitors. As always, I would recommend Freyr again with no hesitation and should the opportunity arise, we absolutely approach Freyr.

    Project Manager,
    A full-service Clinical Research Organization (CRO)
    Based in Florida

  • We are making great progress and we are impressed with Freyr’s commitment to success and willingness to be flexible; you clearly have capable and experienced people in your organization.

    – VP and Head of Regulatory Operations of a Global Top 5 Pharma & Consumer Company

  • We would like to congratulate Freyr team for their excellent service and error free XEVPRM submission with short notice and well within the regulatory timeframe. We sincerely appreciate their technical skills and their extraordinary and selfless effort.

    We are pleased to acknowledge the timely support and recommend Freyr to everyone who are looking for such services.

    – Vice President, Clinical Research & Pharmacovigilance, Microlabs

  • It has been an absolute pleasure working with Freyr over the past few months. Thank you very much for all the hard work – I could not imagine how difficult it would have been without the team being so proactive and diligent.

    I look forward to returning to work with you in January and an exciting new chapter in our time.

    – GRA Operations Program Manager, Top 5 Global Pharmaceutical Company

  • We have made great progress in a short duration and are impressed with the 162 positive acknowledgements from EMA for the XEVMPD submission project.

    I would like to thank the entire team for their support for critical XEVMPD compliance activities.

    Program Manager, Global Top 5 Pharma and Consumer Health Company

  • I would like to thank the Freyr team for all the support they have provided. The Ops team is very satisfied with the level and quality of services from all the resources that we have on board.

    Thanks to their commitment and discipline, we were able to deliver on all key objectives that had been outlined for us in 2014.

    - Head of Regulatory Operations, Top 5 Global Pharmaceutical Company

  • As we near the completion of a major filing, I would like to thank Freyr and recognize the team resource’s performance. It has been a great addition to our team and throughout all the projects, the involvement has been impeccable, illustrating not only professional demeanor, but in-depth skills, dedication, attention to details, willingness to switch gears and deliver timely results.

    We recognize and acknowledge the exemplary performance and look forward to working together.

    – Manager, Regulatory Operations, Global Top 20, $20+ Bn,
    Pharmaceutical Company

  • Great company for eCTD and regulatory supporting is Freyr. I am approaching the end of our first year engagement and we are extremely satisfied with the quality of their resources and leadership. They also have their own suite of tools for publishing eCTD and from what I have seen they offer a very viable publishing solution.

    - Associate Director, Regulatory Technology and Ops,
    Global Top 20 Pharmaceutical Company