Blog Posts
Investigative Site Files and Trial Master Files Should Talk to Each Other
The major deliverable of a clinical study is an organized collection of documents called a Trial Master File (TMF). The FDA (or any regulatory authority) may review the TMF to determine whether the drug, device or diagnostic product is suitable for marketing. The ICH Guideline for Good Clinical Practices (E6 (R2)) Section 8 specifies the…
Read MoreeTMF Placeholder: The Mirage of the TMF
When I was first introduced to the concept of Placeholders (PHs) for eTMF over four years ago, I was SO excited! We were in the process of performing TMF reviews for hundreds (yes, hundreds) of studies. I thought, “YES, FINALLY, some intelligent engineer has figured out a way to determine TMF completeness automatically! We don’t…
Read MoreLMK’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,…
Read MoreLMK’s TMF University to Partner with UNC Wilmington to Prepare Students for a Future in Clinical Research
04 April 2017, Huntersville, NC — LMK Clinical Research Consulting, LLC (LMK), a functional service provider of Trial Master File (TMF) consulting and services, is pleased to announce a partnership between the University of North Carolina Wilmington (UNCW) and our highly rated training program, TMF University. LMK is the first and only TMF services company…
Read MoreLMK Clinical Research Consulting: Sustainable Processes for Clinical Trial Quality
March 2017, Pharma Tech Outlook Magazine – From being stored in cardboard boxes, to sophisticated online databases, the Trial Master File (TMF) has always been an essential component in every clinical trial, despite the evolution. Based on the singular belief that the TMF is the foundation of every clinical trial, Sholeh Ehdaivand has dedicated 15 years…
Read MoreWhat the New England Patriots’ Super Bowl Win Can Teach Us About the TMF
On Sunday evening, millions tuned in to watch the team everyone loves to hate (the New England Patriots, of course) make their ninth Super Bowl appearance in a 1:1 match-up against the Atlanta Falcons. For the first three quarters, it seemed as if the Falcons had “risen” and were on their way to take home…
Read MoreLeading Trial Master File Consulting and Services Provider Also Recognized as Industry Innovator
January 4, 2017 – Huntersville, NC – LMK Clinical Research Consulting, a leader in Trial Master File consulting and services has been named the winner of two Bronze Stevie® Awards: Maverick of the Year and Innovator of the Year in the 13th annual Stevie Awards for Women in Business. The Stevie Awards for Women in…
Read MoreTMF Trackers: Powering Your TMF for Inspection Readiness
Vol. 10, No. 10, October 2016, Journal of Clinical Research Best Practices – A Trial Master File (TMF) consists of the “Essential Documents…that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the…
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