Overview

In a fast-paced Regulatory environment, maintaining the accuracy & completeness of essential documentation stands as the biggest challenge for life sciences organizations involved in regulated clinical trials. In order to get compliant with various region-specific Health Authority (HA) mandates, organizations must ensure their individual site clinical studies are properly compiled and documented for hassle-free inspection and audit. The challenge is to collect, compile and store paper-based documentation and to track the individual site information across geographies. The result could be lengthy clinical trial processes and document mishandling affecting the inspection readiness and ultimately burdened costs. In such scenarios, organizations look for a centralized platform to collaborate the content for effective Trial Master File (TMF) management.

Freyr provides business process and technology solutions that enable companies to effectively manage TMF operational and compliance needs. Focusing mainly on three critical objectives, compliance, TMF quality and timeliness, and completeness, Freyr eTMF (electronic TMF) provides access to study partners for real-time visibility into any clinical study to track the end-to-end study status and enables consolidation of all essential documents required for inspection. Freyr has both functional and technical expertise to handle TMF documentation across following therapeutic areas:

  • Oncology
  • Neurology
  • Respiratory
  • Cardiology
  • Immunology
  • Endocrinology
  • Gynecology
  • Infectious diseases
  • Rare diseases

Apart from providing an easy to use, simple, efficient, cloud-hosted eTMF tool, Freyr offers end-to-end TMF consulting services.

 

Freyr Expertise

TMF Gap analysis

  • End-to-end gap analysis for on-going and completed studies
  • Providing corrective and preventive actions as per TMF accuracy
  • Streamlining process and SOPs to the eTMF strategy and audit readiness criteria

Paper to eTMF Conversion

  • Paper to electronic conversion based on group creation
  • Scanning and indexing of documents as per agreed predefined file formats
  • Quality check of indexed documents
  • Document migration to eTMF or client’s database

Training and SOP writing

  • Providing system and process related training to internal and external stakeholders
  • Role-based training support to CRAs, CTAs, PMs, CTMs and other team members
  • Drafting TMF SOPs for clients as per compliance requirements

Document Processing

  • Deploying dedicated teams for document processing: indexing, QC, and  approvals
  • Capturing relevant metadata while indexing and putting them in appropriate sections and in document management life cycle
  • Quality check for documents based on compliance, SOP and TMF completeness criteria
  • Approving or rejecting documents based on completeness, correctness
  • Comment flags on TMF queries targeting appropriate team or document owners
  • Periodical TMF status reports alerting management on missing documents
  • Processing of all documents to clear backlogs on daily basis and to activate documents based on their milestones and expiry dates

Metrics and Reports

  • On-time client support for customized metrics and report creation related to metadata, site-study or geography
  • Creating dashboards, providing strategies and support to have  audit-ready TMFs

Audit and Compliance Support

  • Audit environment creation to enable audit from anywhere and anytime
  • Training and read-only access to auditors specific to study site or country
  • Comply with 21 CFR Part 11 requirements for electronic signatures
  • Comply with your TMF to current industry standard DIA RM V3 (effective June 2015)
 

Freyr Advantages

  • Highly customizable TMF service or tool based on the customer requirements
  • End-to-end support for quick configuration and deployment with full support for all versions of DIA RMs, roles, reports and workflows which are ready to use
  • Simple and easy-to-use interface for quick adaptability with minimal training required for TMF document creation, exchange and update
  • Business specific real-time workflows enabling accurate reporting for complete, consistent and audit-ready documentation
  • Reports and metrics based insights on TMF completeness, TMF quality, and TMF timeliness to identify and resolve TMF queries and issues of missing or misfiled documents
  • Interactive reports to answer questions about trial progress, departmental performance, and quality
  • Streamlined clinical trials that save time and costs
 
Freyr eTMF

Freyr eTMF is a ready-to-use, simple, efficient and secure cloud-hosted, pay-as-you-go solution for companies to efficiently manage their costly, complex and global clinical trial data across the lifecycle.

Learn more about Freyr’s eTMF Solution

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