Medline, a large manufacturer and distributor of medical supplies, migrated from a paper TMF to an eTMF system, Veeva, in order to have better control and visibility of the condition of their TMF at all times. While the goal was clear, the combination of limited TMF resources to implement the system and the team’s unfamiliarity with the new platform created a perfect storm; Medline quickly realized they were not receiving the return on investment they had anticipated by transitioning to Veeva. To help them over this hurdle, they engaged the services of LMK Clinical Research Consulting (“LMK”) to speed up the learning curve and help the team move forward. LMK provided training, mentorship, and consulting to ensure that the TMF team had a thorough understanding of the TMF, their roles in the day to day management of the TMF, and the skills needed to fully optimize their eTMF system.
LMK implemented a holistic approach to address gaps with the people, process, and technology observed in the Medline’s TMF environment.
People: The key project stakeholders from Medline included the Senior Manager of Clinical Research, the Clinical Trial Coordinator, and the Veeva end-users. LMK’s project team included Connie Orander, Project Lead, and Luisa Monica, TMF Consultant.
Process: LMK provided a comprehensive assessment of Medline’s approach to document management and their use of Veeva. Based on those findings, LMK made recommendations for necessary changes, then established a framework and strategy to develop and update processes, workflows, and procedures. LMK’s TMF University Certified Instructors provided instruction to team members on a variety of TMF topics, from “Fundamental Terms” to “Inspection Readiness” to “eTMF Best Practices.” With a better understanding of the TMF as a whole, the Medline team was then able to think critically about decisions they needed to make regarding document management and their Veeva setup. The information from the training also helped them create processes that would be consistent and sustainable over time. One of the highlights of the focus on “process” was the team’s creation of a TMF Index to be used when filing documents. The index was based on the TMF Reference Model, which had not previously been used by Medline. This TMF Index helped the team answer questions like “Does this document belong in the TMF?” and “Where does this document go?” A final step in this phase was updating Medline’s SOPs to reflect the new processes and changes they had implemented.
Technology: The study team obtained Veeva in October 2018 with the goal of improving their GCP practices, ensuring better Trial Master File management, and easily migrating their clinical trials from paper to their new electronic repository. Medline’s expectation was that the system would provide the tools necessary to help them properly manage a study and accomplish their immediate priorities. Once they began working in Veeva, however, they quickly became dissatisfied with their results. It was not until some of the team attended the TMF Summit in January 2019 that they realized not only their level of non-compliance, but their need for help. After a thorough search for a service partner who could help them get back on track, LMK was retained to provide guidance and support to the TMF team, providing the tools and skills to manage studies in Veeva. All the tools developed were tailored to the team’s specific needs and were supported with instruction along the way. One key component of the engagement was helping the Medline team develop a TMF Plan template that could be modified for a specific study, if necessary, but was otherwise suitable for any study. Two TMF index templates were created and the team was instructed on how to modify them to be study-specific as well. Other tools developed include role descriptions for various Veeva users, QC Criteria Checklists, and an eTMF Access Request Form.
Since working with LMK, Medline’s clinical trials team has implemented many changes to their TMF processes. They now ensure that the Clinical Trial Coordinator reviews all documents before filing them in the TMF. They understand how to make thoughtful decisions about the eTMF system and are confident about which documents should be included at each milestone. One of the big process changes Medline has implemented is taking a proactive approach to their TMF: hunting for gaps, addressing why documents are missing, and quickly resolving the issues identified. They understand they could be subject to a regulatory inspection at any time, and if/when that happens, they need to be confident in the completeness of their TMF.
Their Thoughts on LMK?
“You will never work with a better partner than LMK. LMK is not the kind of partner who solely solves your problems; rather, they teach you how to solve future issues and help you to think critically about your project. Not only are they extremely knowledgeable, but everyone at LMK was helpful, friendly, and approachable. If you have the opportunity to work with LMK, pull the trigger in a heartbeat!”