At LMK, we believe the Trial Master File (TMF) is the foundation of every clinical trial, and a strong foundation is key to the overall health and stability of any clinical program. That is why LMK takes a proactive approach and makes TMF quality a top priority on an ongoing basis – from start through closeout – not just pending an inspection or completion. Don’t let your TMF be a document collection burden at the end of a trial! It is a management tool throughout the life of your trial. LMK can help you plan, collect, and maintain your clinical trial content cost effectively without jeopardizing quality.
What We Do
SOP and 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. Our experienced team offers 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 your content is complete and accurate.
TMF Quality Control
LMK’s TMF experts are ready to help you implement a cycle of QC that continuously verifies the condition of your TMF against your team’s TMF expectations. Our TMF consultants have the decades of experience necessary to reignite document stakeholder engagement and to resolve TMF risks and deficiencies.
LMK’s TMF experts have years of experience developing compliance-based TMF expectations that fit an organization’s unique goals. A Mock TMF Inspection is your most powerful tool to evaluate the story held in your TMF and control regulatory risk.
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Quality TMF Services
LMK takes a proactive approach and makes TMF quality a top priority on an ongoing basis – from start through closeout – not just pending an inspection or completion. Don’t let your TMF be a document collection burden at the end of a trial.
Elite TMF Review Team
The Elite TMF Review Team (ETRT) is a dedicated team who performs TMF QC and remediation (if needed) for risk-based or 100% of the content within the TMF. The ETRT has experience in paper, electronic, and hybrid TMFs and is available to assist you onsite or remotely.
Our unique TMF training program is designed in individual modules that can be mixed and matched among the different experience levels. Our instructors provide quality instruction and guidance to improve your entire TMF operation.