Case Studies
Navigating TMF Complexity: LMK’s Case Study in Effective TMF Management
A small biotech company made the strategic decision to outsource the data management, monitoring, and regulatory functions to a trusted clinical research organization (CRO). However, amidst the transition, they inadvertently overlooked the critical need for a robust process to oversee the Trial Master File (TMF) throughout the study. Recognizing the potential risks and challenges associated…
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The Wolf at the Door: An Inspection Readiness Crisis Case Study
How LMK’s TMF Consultants inspired a TMF leader to look beyond the wolf at the door and achieve TMF success with meaningful TMF metrics. TMF leaders face a growing challenge—a crisis of inspection readiness. Despite rapid advancements in eClinical and eTMF technology, GCP inspection findings continue to rise, a product of increasing clinical trial complexity…
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Trial By Fire: A TMF Training Case Study
How LMK’s TMF University inspired one new hire to overcome her trial by fire and become part of a new generation of TMF professionals. The life sciences industry faces a serious problem—a widespread trial master file (TMF) skills gap. There are simply not enough skilled TMF professionals to support the explosive growth and complexity of…
Read MoreFrom Reactive to Prospective: A TMF Transformation Case Study
How LMK’s TMF experts empowered a growing sponsor to take back the reins of their TMF The Trial Master File (TMF) is the main deliverable of a clinical trial. If a clinical trial’s TMF fails, regulators will act swiftly to protect the safety of patients, and precious clinical data will be thrown into doubt. Despite…
Read MoreLMK Helps Medline, A Large Medical Distributor, Optimize Their Use Of Veeva
Situation: 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…
Read MoreRemediation and Document Management Services for Sponsor
Situation: A late stage biopharmaceutical company working on a fast-tracked Phase 3 study was providing their own document management and recently partnered with an eTMF solution provider to manage their eTMF. Due to eTMF platform constraints and lack of TMF training/awareness, the company found themselves at risk of FDA non-compliance. With over 4000 backlogged documents…
Read MoreLMK’s TMF Mentoring & Training Services Improve International Company’s Process
Situation: A large international pharmaceutical company implemented a new centralized TMF program. As a result of the new program, the company lacked the trained resources needed to effectively manage the TMF program. LMK provided training and professional mentorship for the newly formed TMF Lead, TMF Project Manager and TMF Document Associates roles. LMK Solutions: For…
Read MoreLMK’s Oversight TMF QC Process Ensures TMF Completeness
Situation: A small biotech company outsourced the data management, monitoring, and regulatory functions of their oncology program to a clinical research organization (CRO). Unfortunately, the biotech company did not have a process in place to perform oversight of the Trial Master File (TMF) throughout the duration of the study. The sponsor contracted LMK to provide Oversight Quality Control…
Read MoreLMK Navigates the Process of Selecting the “Right” eTMF Solution: Saves Client $1.5M and Implements eTMF Solution 5 months Ahead of Schedule
Situation: A mid-size pharmaceutical company decided it was time to move their paper TMF into an electronic Trial Master File (eTMF) system. With so many eTMF vendors on the market and all the different functionality that these systems can perform, our client was a bit overwhelmed and requested LMK’s support with selecting an eTMF vendor.…
Read MoreLMK’s eTMF Indices Quality Review Process Ensures the Highest Level of TMF Quality
Situation: LMK was contracted by a large pharmaceutical company to ensure that all of the Trial Master File (TMF) indices (ie, regulatory submission) were present for their “high-risk” studies according to each study’s specification. LMK Solutions: To verify TMF completeness, LMK resources performed a gap analysis on the electronic TMF (eTMF) processes using our customized…
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