LMK Clinical Research Consulting is a leader in Trial Master File (TMF) document management services and solutions for the life sciences industry.
Our experts can support your TMF strategies in numerous ways, learn more.
Functional Service Provider
Reduce resource burdens and increase quality by taking an “a-la-carte” approach – outsourcing only what you need to help manage your clinical trial content.
Document Quality Control
Ensure superior document QC standards by using expert QC services for some or all of your TMF documents and files.
TMF Quality Control
Implement a cycle of Quality Control that continuously monitors the condition of your TMF.
SOP & Process Development
Develop a foundation of sustainable SOPs, work instructions, and processes to ensure that your TMF can be complete, accurate, and inspection ready at all times.
eTMF Selection & Implementation
Which eTMF solution is right for you? Ensure an orderly transition with a stable foundation of detailed processes, whether transitioning from paper or between two eTMF systems.
TMF Reference Model Implementation
Establish clear expectations among all stakeholders with accurate indexing of documents within the TMF Reference Model framework.
Document Filing & Indexing
Eliminate document handling latency by engaging LMK's team of TMF professionals to ensure your TMF is inspection ready upon closeout.
Training & Stakeholder Engagement
Training and Stakeholder Engagement are the cornerstones of every optimally functioning TMF department. Our TMF Professionals can help you reinvigorate your team's approach to managing every Trial Master File.
Metrics Driven Process Improvement
Develop metrics (per Metrics Champion Consortium guidelines) to assess the completeness and quality of your TMF on an ongoing basis.