Case Studies

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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