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Case Studies

Get the latest updates from the LMK Clinical Research Team! New case studies are released periodically throughout the year.

Remediation 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

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LMK’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

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LMK’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

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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

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

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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