The Top 4 Horror Clichés Lurking in Your TMF With Halloween finally here, many of us are curling up on the couch with a bucket of candy and binge-watching horror movies. There are an abundance of these films to stream: cult classics, who-done-its, edge-of-your seat thrillers, gory slasher films, and the ever-popular zombie uprising. Some

In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the

“Life starts all over again when it gets crisp in the fall.” This famous passage from Fitzgerald’s novel, The Great Gatsby, suggests that the fall season is a time of renewal rather than the last hurrah before the dead of winter. As we celebrate fall and contemplate winter, we should also consider the changing seasons

In a recent Veeva survey, 81% of respondents reported the ongoing use of manual processes (like spreadsheets and emails) to manage study start-up.[1] More worryingly, despite the recognized need for increased clinical operations transparency and efficiency, the same survey report cites that study start-up is no faster than it was a decade ago, even considering

Now that summer has come to an end, we are rolling up our sleeves and working hard to solve your most pressing TMF challenges. As part of our mission to ensure TMF success for all, we’re attending two important conferences: The Veeva R&D Summit, September 8th through the 10th in Philadelphia, Pennsylvania, and the Trial

Completeness is an essential component of TMF health. A TMF’s purpose is to tell the story of a clinical trial. An incomplete TMF is like a book with missing pages—even if the story is well written, it is inaccessible to any reader. In a few previous blog posts we’ve discussed how an incompleteness crisis can

In our last post, we discussed the growing TMF completeness crisis. More often than ever, sponsors are discovering that upon closeout the TMF is woefully incomplete. Delays in TMF closure, as discussed in the last post, increase regulatory risk, derail regulatory submissions, and can endanger an entire project. Although a few key incompleteness mitigation strategies

With increasing frequency, TMF stakeholders face a completeness crisis at TMF close-out.  Delays in TMF closure increase regulatory risk, derail regulatory submissions, and can endanger an entire project. Sponsors, when asked about the growing trend of TMF incompleteness, are likely to cite a challenging relationship with a CRO. Regulators, however, have little sympathy for this

Your choice of eTMF system, performance metrics, quality system, and any other TMF initiative are critical, but ultimately the success of your TMF is secured through the engagement and competency of your TMF team. At LMK, we believe the most important features of your TMF are people and that innovative TMF training is as important

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

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

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

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

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,

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