TMF(Trial Master File)

Drive innovation across Healthcare Providers, Medical Devices, Pharma and Biotech industries and boost the efficiencies of healthcare eco system operations with high-quality software, engineering, industry domain and talent solutions developed by EZEN .

TMF Services :

  • Quality
  • TMF Quality Control
  • Inspection, Submission Readiness
  • Archive Review
  • TMF Re-mapping
  • Interim Resources
  • Sponsor Archiving
  • Investigator Archiving
  • Consultancy
  • eTMF Support

Services :

EZEN offers a wide range of TMF related services, supported by a unique combination of clinical trial knowledge, document management skills, regulatory understanding, and technical expertise.

TMF/eTMF Consulting – With our team of experts in our client solutions division, EZEN offers services to assess client’s existing business processes and to identify where process and productivity improvements can be made.

eTMF Business Processing – EZEN uses secure IT connections and remote scanning to process TMF documents

TMF Quality Control

Trial Master File Quality Control (TMF QC) is carried out by our team of trained and experienced individuals who check the TMF documentation at several key stages through the clinical trial process, often upon receipt of documents and pre-archive, at the Sponsor site, the Contract Research Organization (CRO) site or EZEN offices.
EZEN can also offer:

The TMF Health Check– a snapshot view of the state of your TMF

TMF remediation of issues raised during QC to follow up with sites and CROs

TMF gap analysis and completeness assessment

Level 1 QC – Section Level Checking

This high-level check is to ensure artifacts are accounted for (absent or present) in the TMF. The general standard of filing, including accuracy and reverse date ordering is also checked. The output of Level 1 QC is a summary checklist detailing artifacts with missing documents.

Level 2 QC – Document Level Checking

Includes high-level section checks as defined in Level 1, including document quality checks for dates, signatures, versions, and completeness and cross- checks to ensure associated documents are present and complete. The output is a series of reports based on the TMF structure per trial, country, or site, allowing the data and findings to be assessed and presented in a variety of ways.

Level 3 QC – Compliance & Oversight Checks

This Includes section and document level checking, as defined in Level 2, including a further review of documents and processes to check for compliance and oversight. The output is a comprehensive report customized to your requirements.

Inspection Readiness

  • Is your TMF ready for your next regulatory inspection?
  • Can your team effectively support inspection-related activities?
EZEN’s experience with TMF and eTMF requirements from a Regulatory Authority perspective is unmatched.
Our team of experienced document experts and consultants will help you prepare your TMF ahead of inspection through a selection of services at the Sponsor site, Contract Research Organization site (CRO), Investigator site or our offices. EZEN can help clients prepare their TMF through a variety of services:
  • TMF QC
  • TMF consolidation and re-mapping as appropriate
  • Supporting client teams to understand EZEN processes (EZEN teams at client sites)
  • Store TMF documents as required
  • Host inspection if required
  • Client site support – organization, interview scribing

Interim Resources

Contract Resources

The EZEN Clinical is a team of trained and experienced industry professionals; who provide worldwide contract and short term project based support to clients across the industry. This resources can be provided at either the client’s or EZEN's offices. EZEN Clinical can provide individuals under client management teams or EZEN management.

EZEN's Clinical offers an independent and flexible approach to ensuring projects are appropriately resourced and managed whether on a global or local level. Working closely with clients to understand their specific business needs, the we will assign appropriate individuals to complete the project from three core service teams – Team 1, 2 and 3.

Team 1 - Consists of industry trained Clinical Project Administrators, Study Managers

Team 2 - Typically comprised of Clinical Trial Administrators and

Team 3 - consists of: Project Managers, Trial Master File Specialists, Clinical Research Associates (CRAs), Auditors, Technical Writers, Clinical Data Entry specialist, Pharmacist Consultants etc. The typical tasks are detailed below:

The EZEN Clinical staff is fully trained in clinical research guidelines including GCP, ICH, FDA, EMEA the EU Directives and local requirements. The team has a wealth of experience within clinical research gained from working on a range of commercial projects within large and small pharmaceutical, medical device, CRO and biotechnology companies.

Enhanced by our Freelance Register, the EZEN team has additional flexibility for resourcing projects, ensuring that all projects are allocated to appropriately trained and experienced staff to ensure project deliverables are met.

eTMF Support

  A significant number of pharmaceutical and biotechnology companies already have a document management system that is integral to their daily operations. A number of these companies have extended their document management system to encompass elements of an eTMF through either in-house customization of their platform or through the purchase of an external (vendor) eTMF solution.

  EZEN offers a completely customized client solution. By using secure IT connections and remote scanning, EZEN can support all systems. All essential TMF paper documentation can be maintained either at the client site or at EZEN's offices. To date, we have worked with eight different eTMF systems, mostly based on SharePoint or Documentum.