LMK Blog

Informed Consent: The Story Your TMF Needs to Tell

October 5, 2017

Of all the documents making their way into your TMF, the informed consent form is the most important. Although you probably already knew this fact, do you know how it came to be this way? Why do auditors and inspectors review 100% of the informed consent documents, and typically do so before reviewing anything else?…

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When it comes to Inspection Readiness – Knowledge WINS.

October 5, 2017

Per GCP Directive 2005/38/EC: Chapter 4 Article 16, the Trial Master File (TMF) is THE basis for an inspection by the Regulatory Authority. The definition of TMF Inspection Readiness therefore includes being prepared for a regulatory inspector to reconstruct the clinical trial conduct, using all pertinent data and metadata in the TMF. Essentially, this means…

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When Medicines Go On Trial, LMK Makes Sure They Get It Right

August 24, 2017

SUPPLIER DIVERSITY – WBENC CERTIFIED Editorial Sponsored by Bristol-Myers Squibb By Arthur Schurr Bringing a medicine to market is not easy. It takes time. It takes money. It takes research. But it also takes something else that is surprisingly often overlooked—documentation. And that’s exactly why Sholeh Ehdaivand founded LMK Clinical Research Consulting (LMK). “I had been…

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Investigative Site Files and Trial Master Files Should Talk to Each Other

August 14, 2017

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…

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Welcome to LMK Clinical Research

August 3, 2017
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eTMF Placeholder: The Mirage of the TMF

June 6, 2017

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…

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LMK’s eTMF-Agnostic TMF Completion Process Revolutionizes Approach to Inspection Readiness

May 31, 2017

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,…

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LMK’s TMF University to Partner with UNC Wilmington to Prepare Students for a Future in Clinical Research

April 4, 2017

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…

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LMK Clinical Research Consulting: Sustainable Processes for Clinical Trial Quality

March 11, 2017

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…

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