Change isn’t easy. Although your current TMF system may no longer align with your team’s goals, the prospect of migrating to a new eTMF system can be intimidating. Selecting the correct eTMF system for your team’s needs is only an initial step. Deployment of a new eTMF system requires training, updated processes and SOPs, complete

About LMK’s Mindful TMF Series Your palms are sweaty. Your pulse races when you hear the news. You’d do anything for a few more hours to prepare and you might work all night. It’s TMF inspection day and now it’s too late to make a meaningful change. At LMK Clinical Research Consulting, we know the

About LMK’s Mindful TMF Series Your palms are sweaty. Your pulse races when you hear the news. You’d do anything for a few more hours to prepare and you might work all night. It’s TMF inspection day and now it’s too late to make a meaningful change. At LMK Clinical Research Consulting, we know the

About LMK’s Mindful TMF Series Your palms are sweaty. Your pulse races when you hear the news. You’d do anything for a few more hours to prepare and you might work all night. It’s TMF inspection day and now it’s too late to make a meaningful change. At LMK Clinical Research Consulting we know the

TMF Stress Your palms are sweaty. Your pulse races when you hear the news. You’d do anything for a few more hours to prepare and you might work all night. It’s TMF inspection day and now it’s too late to make a meaningful change. TMF stress is why clinical documentation might be the least loved

In a recent blog post, Sholeh Ehdaivand, President and CEO of LMK Clinical Research Consulting, discussed the benefits of migrating from paper or hybrid TMF to eTMF. In her blog post, Sholeh wrote at length about the potential of a “shiny, new eTMF system”. Simply put, the transformative potential of the eTMF is astounding.  Beyond

The New Year is a time to examine old routines and make new ones. Early in the year, we all can embrace a blank calendar and blank slate of ideas, goals, and resolutions. This year, at LMK, we’re challenging you to take up our resolution – to ban the Note to File (NTF). Yes, our

About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise. Celebrating TMF

About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise. Celebrating TMF

With lights in the trees, wreaths on the doors, and Mariah Carey’s ‘All I Want for Christmas’ playing on every other radio station, it must be that time of year again… time to prepare for the annual Trial Master File Summit in Orlando! This year, LMK Clinical Research Consulting (LMK) is feeling extra festive, because

LMK Clinical Research Consulting recognizes our debt to all veterans, past and present. We acknowledge their sacrifice that ensures all Americans may share in our most important principles of freedom, justice, and liberty. These fundamental principles are the foundation of all worthwhile scientific and medical advancement. November 11th, 2018 marks the 100th year anniversary of

About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise. Celebrating TMF

About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise. Celebrating TMF

About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise.  Celebrating TMF

About LMK’s How-To Series What makes someone an expert? Does it take a title, authority, or skill? At LMK we believe an expert, above all, is someone with the heart of a teacher—someone who doesn’t just possess advanced knowledge but is also willing to share that knowledge for the benefit of all. LMK’s commitment to

In part one of our two-part series on FDA inspection of sponsors, we confirmed that no matter the extent of the responsibility delegated away to a CRO or other service provider, “the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor” (ICH GCP 5.2.1). We also discussed the

Of all the challenging aspects of managing a Trial Master File (TMF), grappling with a high number of protocol amendments nears the top of the list.  With every new amendment comes the need to produce, track, and file all the documents that have changed in tandem with the amendment. The number of documents that may

One of the golden rules of Trial Master File (TMF) management is to avoid duplicate filing of documents.  We all know that the primary objectives of the TMF is to provide step-by-step documentation of the clinical trial and to protect the rights of patients.  It is also vitally important for the TMF to facilitate, and

Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the Trial Master File (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not

Discussion of FDA inspections, whether for cause or part of a routine GCP inspection, usually centers on the inspection of trial sites and the CROs who are tasked with managing them. The reason for the disproportionate focus on the inspection of trial sites and CROs stems from two material factors: the patient centered nature of