Be Inspection Ready from Day One
Inspection Readiness. Two words that can ignite worry, fear, and stress. At LMK, we work with our clients to alleviate those concerns and ensure that you are inspection ready from Day One. We believe that the clinical trial content is the foundation of every clinical trial, and a strong foundation is key to the overall health and stability of any clinical program. LMK takes a proactive approach and makes clinical trial content quality a top priority on an ongoing basis – from start through closeout – not just pending an inspection or trial completion.
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.
Don’t let your content be a 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. We offer our clients a combination of expertise, tools, processes, and extensive knowledge of the clinical drug development process. Our experts will assess your study requirements and processes and create a plan customized to meet your specific needs.
What we do
Why Choose LMK
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
LMK's Strategic Approach
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.
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.
LMK Ready is LMK’s unique service offering specialized designed for small and medium sized life sciences companies. LMK Ready is a way to leverage an entire TMF Operations organization – TMF Consultants, Project Managers and Document Specialists for your company without having to incur the costs of a full-time headcount. More important than the cost considerations, LMK Ready provides broad-based and on-demand perspective around best practices in eTMF optimization, inspection readiness and overall TMF quality.