Clinical Research Services

Ensuring TMF quality is the single most important deliverable of a clinical trial.

Given the current attention to the TMF, regulatory agencies can show up at any time to perform a TMF Audit. Make sure your trial documentation is always inspection ready by having the experts at LMK guide you through the implementation of our proven tools for successfully managing a TMF. A mock TMF Inspection is your most powerful tool to evaluate the story held in your TMF and control regulatory risk; our team can provide you with peace of mind by creating or transforming your TMF into an inspection-ready trial management tool.

TMF Functional Service Provider

Functional Service Provider

As a premier TMF Functional Service Provider (FSP), LMK offers comprehensive TMF services specializing in the strategic development, project management, and quality control of documents and content that support clinical development. We offer the flexibility to support you with whatever tasks you choose – from staff augmentation to full support of your TMF, we can provide what you need, when you need it.

TMF Essentials - Document Quality Control

Document Quality Control

TMF Document QC is the core of successful TMF managment. Our TMF Professionals can help you assess your document QC standards and provide document QC services for some or all of your TMF documents and files.

TMF Quality Control

TMF Quality Control

The quality of the TMF as a whole is often overlooked as part of the ongoing management of the Trial Master File. LMK’s TMF Professionals can help you implement a cycle of QC that continuously monitors the condition of your TMF to ensure continuous inspection readiness.

SOP & Process Development for the Trial Master File

SOP & Process Development

LMK’s TMF experts know that your TMF can be complete, accurate, and inspection ready at all times with a foundation of sustainable SOPs, work instructions, and processes. We can provide custom and comprehensive solutions tailored to the specific needs of your business through the development of meaningful SOPs that ensure the System of Record for all of your content is complete and accurate.

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eTMF Selection & Implementation

Change is good. Whether transitioning from a paper to an electronic TMF, or between two eTMF systems, LMK’s team of experts are ready to ensure a smooth transition with detailed processes that will provide guidance for your team. LMK can support you with eTMF training and empower your team to turn TMF drudgery into TMF mastery—transforming your TMF into a competitive advantage.

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TMF Rescue

When TMF challenges arise, you’re not alone. LMK's experts turn your concerns into confidence. We conduct a thorough gap analysis to pinpoint areas of concern, then tailor a remediation plan to bring your Trial Master File up to regulatory standards. Our strict quality control checks ensure every detail is accounted for. Plus, with our proactive training, your team will be empowered to maintain TMF excellence.

TMF Reference Model Implementation

TMF Reference Model Implementation

As TMF Reference Model Subject Matter Experts, LMK’s TMF Professionals specialize in indexing documents within the TMF Reference Model framework. LMK can work with your team to develop a complete TMF ‘Table of Contents’ that will establish clear expectations across your organization.

Trial Master File Document Filing & Indexing

Document Filing & Indexing

LMK’s TMF Professionals understand the need for flexibility when it comes to conquering document management challenges. Our TMF experts quickly pivot in response to changing document management resource needs, eliminating document handling latency and ensuring your TMF is always inspection ready.

TMF Training & Stakeholder Engagement

Training & Stakeholder Engagement

Training and Stakeholder Engagement are the cornerstones of every optimally functioning TMF department. LMK's accredited and non-accredited training programs can re-energize teams and help instill a refreshing new perspective on TMF accountability.

Metrics Driven Process Improvement for the Trial Master File

Metrics Driven Process Improvement

"If it wasn't written down, it never happened." LMK will put the appropriate metrics in place to guarantee the success of your TMF so that you will be 100% Inspection Ready.