LMK’s eTMF-Agnostic TMF Completion Process Revolutionizes Approach to Inspection Readiness
May 31, 2017
HUNTERSVILLE, N.C.–(BUSINESS WIRE)–LMK Clinical Research Consulting, LLC (LMK), a functional service provider of Trial Master File (TMF) consulting and services, is pleased to announce “LMK Complete,” an eTMF agnostic process to determine TMF completeness to support regulatory inspection readiness.
[gdlr_quote align=”left” ]LMK Complete solidifies the most important aspect of any clinical trial, which is the successful maintenance of an inspection ready TMF. It provides a stable blueprint for life sciences organizations to manage their TMF for the foreseeable future[/gdlr_quote]
Performing TMF Quality Control (QC) and determining which documents are expected throughout the course of a clinical trial can be a daunting, resource draining process for most life sciences organizations. LMK Complete is a comprehensive TMF QC review process based on ICH E6 Release (R2) requirements, Six Sigma principles and Metrics Champion Consortium (MCC) TMF metrics recommendations to measure TMF health.
The LMK Complete service offering is performed by TMF University certified associates at LMK. These highly trained and specialized resources understand clinical operations and TMF requirements allowing precise determination about expected documents for all phases of clinical trials across all therapy areas.
LMK Complete can be utilized by life sciences organizations to prepare for a regulatory inspection, ensure oversight of partners/vendors, plan for a merger or acquisition, and assist with study close-out and archive activities. Confirmation of TMF completeness through the innovative LMK Complete process can be a vital metric in determining overall study health.
LMK Complete is an innovative eTMF agnostic process that can be utilized across any organization regardless of the TMF format (electronic, paper or hybrid).
“LMK Complete solidifies the most important aspect of any clinical trial, which is the successful maintenance of an inspection ready TMF. It provides a stable blueprint for life sciences organizations to manage their TMF for the foreseeable future,” stated LMK President and CEO, Sholeh Ehdaivand.
Maintaining a complete and accurate TMF is a vital part of maintaining a healthy clinical program and LMK Complete can support this critical regulatory requirement.
Interested in learning more? Please join LMK for a complimentary webinar on Thursday, 08 June 2017 at 11am to learn more about LMK Complete and tips on how to improve your TMF QC process. Register here: http://bit.ly/2ppmDU7
LMK Clinical Research Consulting, LLC (LMK), is a functional service provider of Trial Master File (TMF) consulting and services. LMK is a trusted leader for its dedication, quality solutions, and expert services in TMF. LMK is a woman-owned business certified by the Women’s Business Enterprise National Council. For more information about LMK, visit www.lmkclinicalresearch.com.
LMK Clinical Research Consulting, LLC
Isaiah Howard, 704-464-3291
Director of Marketing