The LMK Advantage
Times are changing and now, more than ever, you need document management tools that help you make smarter decisions and gain the competitive advantage.
LMK can help.
TMF Management Process
We are flexible and offer a full range of document management services - from SOP development through archive. Our team members are TMF experts and have extensive knowledge in clinical trial drug development and the TMF. As part of your study team,we provide guidance as subject matter experts ensuring TMF compliance to guarantee quality deliverables..
LMK TMF experts will work with you throughout the life cycle of your product to effectively plan, collect, and manage your clinical trial documents
on an ongoing basis. Our team performs TMF QC and remediation across Functional Lines, ensures TMF appropriateness and accuracy, and provides additional TMF support during an audit inspection
TMF Reference Model
You haven't adapted the TMF Reference Model yet? Our team can review your SOPs to determine which document types from the TMF Reference Model are applicable to your company.
We are an eTMF agnostic company and are fullly trained in all of the major eTMF technologies. If you need to streamline your TMF process and want to have your TMF content in one electronic repository, we can help. Our experienced resources will migrate your TMF content quickly and efficiently ensuring instant access to your trial content.
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 review the content. Don't be caught off guard. Make sure your trial is ready by having the leaders in TMF management at LMK provide our proven TMF QC processes.
Dedicated 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. With expertise in clinical trials and TMF management, the ETRT reviews your TMF content in a timely manner using an established process and tool to perform TMF QC that highlights gaps and discrepancies within the TMF.
By utilizing LMK's ETRT, you benefit from increased process efficiency and TMF compliance - saving you time and reducing your costs while increasing the quality of your TMF:
Identifies and documents true discrepancies and potential gaps within the TMF. Resolves discrepancies rather than generating a long list of queries for your team to resolve.
Ensures your TMF is inspection ready at all times throughout the study through routine TMF QC - providing you with another level of validation.
Reduce costs and expedites timelines through "effecient" TMF content QC and remediation.