LMK Clinical Research Consulting considers the TMF to be the foundation of clinical trials, we follow established processes to attain the highest TMF quality. A quality TMF is the fundamental goal of every clinical trial and critical to its success as it is the tool used to demonstrate compliance of a trial, and it allows for verification of the integrity of the trial data and patient safety. The TMF is the only tangible product at the conclusion of a study; therefore, it should be inspection ready at all times.

LMK Complete is an innovative eTMF agnostic process that can be utilized across any organization regardless of the TMF format (electronic, paper or hybrid). After reviewing your document repository and file process, our team of experts creates a customized process that addresses your needs.

The TMF must contain all documents that permit the evaluation of study conduct and data quality. If your TMF is not up-to-date or quality controlled performed on an ongoing basis—no problem—we can help. Our qualified team performs file remediation to identify potential quality gaps and creates a customized action plan for correcting these discrepancies.

TherAlign™ - The First of its Kind!

What is LMK's TherAlign™ Solution?

TherAlign™ is an innovative resourcing model that aligns TMF experts by therapeutic area and/or functional line.

LMK TMF experts have a deeper understanding of the therapeutic area and the TMF content and documents. They deliver customized services to meet your project’s specific needs and requirements.

What Type of Services Does TherAlign™ Support?

  • Overall TMF management
  • Quality control and remediation
  • eTMF implementation including document mapping
  • eTMF document reading

How Do You Benefit From TherAlign™?

  • Higher quality document management
  • More expertise and experience drawn from a wider experience base
  • Increase in objectivity
  • Clear and concise insight into what is expected within your TMF
  • Decrease in mediation, time and cost

Success Story – TherAlign™ Solution

LMK Complete is an innovative eTMF agnostic process that can be utilized across any organization regardless of the TMF format (electronic, paper or hybrid). After reviewing your document repository and file process, our team of experts creates a customized process that addresses your needs.

Situation

A large international CRO was preparing to send TMF files back to the sponsor for a large oncology program that recently closed its last clinical trial. Prior to the shipment, the CRO’s management team wanted a detailed review of the TMF. Unfortunately, the CRO resources were assigned to new studies. The CRO contracted LMK for support in reviewing the TMF and remediating discrepant files.

LMK Assigned the “Right People”

LMK assigned TherAlign™ TMF experts with experience in oncology who were former clinical research associates, data managers, safety specialists, regulatory submission managers, and a statistician.

TherAlign™ Solution In Progress

1. Reviewed the CRO’s and the clients TMF SOP’s and the TMF Plan for the program
2. Created the TMF QC and Remediation Plan
3. Reviewed the files and remediated the discrepant documents

TherAlign™ Results

The LMK team decreased the CRO’s overall TMF QC fail rate by 4%. The CRO returned the inspection ready files to the sponsor.

As a result of LMK’s detailed review and recommendations, the CRO and LMK established an alliance and agreement that the TherAlign™ team would review all legacy TMF files priors to shipment to the sponsor.

LMK also helped the CRO develop TMF QC and remediation processes whereby the functional lines/document owners at the CRO reviewed their respective files for ongoing studies on an ongoing basis

Request a complimentary consultation.LMK Complete can be the difference your TMF needs. Contact our TMF Professionals today to learn how they can help.