eTMF & DOCUMENT MANAGEMENT

TMF Services & Support

Long-term and short-term solutions for TMF and Document Management Support

When you work with our experienced team, you can be assured that we will manage TMFs for your clinical trial in addition to supporting various other activities.  Flexibility is our strength; we can work within multiple systems to accommodate your unique needs.  We understand that visibility and transparency into the TMF process is important to you, and ensure operational efficiencies by using only the most cutting-edge, cloud-based and integrated solutions.

You can work with our TMF experts to support a variety of initiatives, including:

  • End-to-end Active TMF Management
  • eTMF Implementation and Support
  • eTMF System Administration
  • TMF Migration Execution
  • Process Development
  • TMF Governance and Quality Assessments

PROFICIENCIES

Our global Document Management team has decades of industry experience, including active representation on the TMF Reference Model Steering Committee and Change Control Board. We can provide you with expertise, guidance and support in the following areas:

ACTIVE TMF MANAGEMENT

End-to-end TMF management and support including TMF set-up, TMF Plan creation, filing structure development based on the Reference Model, document processing, TMF Reviews, closeout and transfer of final TMF or long-term archival.

eTMF IMPLEMENTATION

Implementation support for Sponsor-owned eTMF systems, including design and configuration participation, testing and validation, training and procedural document design, and deployment / system launch activities.

eTMF SYSTEM ADMINISTRATION

Ongoing, active support of Sponsor-owned eTMF systems at a system administration level. May include report and dashboard development, user account management, change control requests, and additional technical support as needed.

TMF MIGRATIONS

Paper to TMF, eTMF to eTMF, other system to eTMF full migration support and conduct. Includes planning, validation, mapping, execution.

PROCESS DEVELOPMENT

Creation of TMF SOPs and Work Instructions, templates for TMF Plans and TMF Indexes, training materials, and other relevant guidance documents as needed. Gap analyses can be performed on existing procedural documents to identify areas of need and improvement.

GOVERNANCE AND QUALITY ASSESSMENTS

Process optimization, KPI development, inspection readiness preparation and support, and overall quality assessments of the TMF.

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