Case Studies

The Wolf at the Door: An Inspection Readiness Crisis Case Study

March 31, 2023

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

February 17, 2023

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…

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From Reactive to Prospective: A TMF Transformation Case Study

September 13, 2022

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…

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LMK Helps Medline, A Large Medical Distributor, Optimize Their Use Of Veeva

May 27, 2020

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…

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Remediation and Document Management Services for Sponsor

January 17, 2019

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…

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LMK’s TMF Mentoring & Training Services Improve International Company’s Process

January 4, 2019

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…

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LMK’s Oversight TMF QC Process Ensures TMF Completeness

January 3, 2019

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…

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LMK Navigates the Process of Selecting the “Right” eTMF Solution: Saves Client $1.5M and Implements eTMF Solution 5 months Ahead of Schedule

January 2, 2019

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.…

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LMK’s eTMF Indices Quality Review Process Ensures the Highest Level of TMF Quality

January 1, 2019

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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