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LMK Blogs

Get the latest updates from the LMK Clinical Research Team! New blogs are released periodically throughout the year.

LMK Named an INC 5000 Fastest Growing Company For The Second Year In A Row

HUNTERSVILLE, August 12, 2020 – Inc. magazine today revealed that LMK Clinical Research Consulting, LLC is No. 2872 on its annual Inc. 5000 list, the most prestigious ranking of the nation’s fastest-growing private companies, with a three-year growth rate of over 138%. The list represents a unique look at the most successful companies within the

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How to Build a Strong TMF

Building a strong TMF that is reliable, credible, and inspection ready at all times is crucial for the reconstruction of any clinical trial. Successful TMF trial management can be facilitated by:   Standardizing Processes: Implementing SOP’s for filing or QCing a TMF document ensures your team is consistently delivering the same quality of work. An

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GCP INSPECTIONS METRICS REPORT: KEY CONCLUSIONS

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) is renowned and feared for its high expectations regarding the Trial Master File (TMF). MHRA expects your TMF to be “the story of how the trial was conducted and managed.” Given the MHRA’s expectations, it is no surprise that the TMF is well represented among

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Meet the LMK Team: Connie Orander

“It is teamwork that remains the ultimate competitive advantage, both because it is so powerful and so rare.”  – Patrick Lencioni   Connie Orander, one of our TMF Consultants, embodies a great team member. Connie has been with LMK for slightly over a year. She is always willing to lend a hand to her coworkers.

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2019 TMF RM Survey Results Summary

The Trial Master File Reference Model (TMF RM) group has announced the results of their 2019 TMF survey, which was launched in November 2019. The purpose of the TMF Survey is to gather industry-wide insights of TMF/eTMF management and knowledge of the reference model. The data collected is used to identify new TMF trends, measure

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Meet the LMK Team: Sheila Garland

TEAM. Together. Everyone. Achieves. More.   To keep our “Meet the Team” blog series going, we interviewed Sheila Garland, who has worked at LMK for a little over a year. Sheila tells us what she enjoys about her key role at LMK, what skills she attributes to her success, and what she would like to

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Emails: To File or Not To File?

Emails.  It’s a love – hate relationship.  We loathe a full inbox when returning from vacation because those emails represent how far behind we are with our work.  Even during normal business hours, nonstop emails can draw our attention when we are trying to close out our workday.  It can be hard to turn off

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Meet the LMK Team: Allison Grosik

At LMK, we acknowledge we could not be successful without our incredible team. This month we interviewed Allison Grosik, one of our dedicated TMF Support Analysts. Allison has been with the team for 6 months. Allison shares with us what she enjoys about her key role at LMK, her most memorable project, and her retirement

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Meet the LMK Team: Marielle Hewitt

At LMK, we consider our dedicated team the key to our success. This month we interviewed Marielle Hewitt, one of our diligent TMF Support Analysts. Marielle has been with our organization for five months, and her contributions are crucial to our success. Learn about Marielle’s key role at LMK, her most memorable project, and the

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Meet the LMK Team: Jason Badamo

“Great things in business are never done by one person; they’re done by a team of people” – Steve Jobs. This month we interviewed Jason Badamo, TMF Auditor, who has been a member of the team for one and a half years. Learn what Jason’s proudest moment at LMK is, his most memorable project, and

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Meet the LMK Team: Jackie Morrill

At LMK, we believe that our dedicated team is the key to our success. This month we interviewed Jackie Morrill, our Executive Director of Clinical Operations, who has been with the team for 4 years. Jackie tells us what she enjoys about her key role at LMK, her most memorable project, and what her go-to

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Know Your Regs: A TMF Regulatory Overview

Part 3: 21 CFR Part 11 As part of a recent webinar series, LMK Clinical Research Consulting was lucky to host Marie-Christine Poisson-Carvajal, Head of TMF & Registry Operations at Pfizer, to discuss the main regulations that predicate the Trial Master File. During the webinar, Marie-Christine outlined the four most common relevant regulatory authorities and

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3 Ways Your eTMF Can Be the Champion of Your Clinical Trial

Visit LMK at the 9th Annual TMF Summit Now that the holiday season is over, the TMF experts at LMK are refreshed, reenergized, and ready to help you tackle your most pressing TMF challenges in 2020. As part of our mission to ensure TMF success for all, we’ll be attending the 9th annual Trial Master

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A Bright Idea Will Bring Us Together: Happy Holidays from LMK

Like so many tangled strands of holiday lights, making sense of an unhealthy TMF can bring out the opposite of holiday spirit. Still, LMK’s TMF experts have been working all year on the most challenging TMF problems. They have found obstacles that may at first seem impassable can be overcome when the right technology and

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Know Your Regs: A TMF Regulatory Overview

Part 2: MHRA Gray Guide As part of a recent webinar series, LMK Clinical Research Consulting was lucky enough to host Marie-Christine Poisson-Carvajal, Head of TMF & Registry Operations at Pfizer, to discuss the main regulations that predicate the trial master file. During the webinar, Marie-Christine outlined the four most common relevant regulatory authorities and

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The Powerful Benefits of TMF Gratitude

At home with our family and friends and surrounded by delicious food and drink it is easy to count one’s blessings. The benefits of gratitude, however, are available all year long and extend far beyond the border of the Thanksgiving table. LMK’s TMF experts have even found that gratitude, a quality of open appreciation for

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Know Your Regs: A TMF Regulatory Overview

Part 1: ICH GCP As part of a recent webinar series, LMK Clinical Research Consulting was lucky enough to host Marie-Christine Poisson-Carvajal, Head of TMF & Registry Operations at Pfizer, to discuss the main regulations that predicate the trial master file. During the webinar, Marie-Christine outlined the four most common relevant regulatory authorities and their

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TMF Horror Cliches

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

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5 Narrative Elements That Will Reveal The Masterpiece In Your TMF

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

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Constant Renewal: The Perennial TMF and GDP

“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

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Best Practices: Smart Study Start-Up Leads to TMF Success

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

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Best Practices: Contacting Trial Sites for Missing TMF Documents

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

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Recovery: The TMF Completeness Crisis

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

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Prevention and Remediation: The Completeness Crisis

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

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Transform Your TMF Team: The Rewards of TMF Training

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

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The Four P’s of Migration

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

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The Mindful TMF: Acceptance and Letting Go

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

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The Mindful TMF: The Non-Judging and Patient TMF

  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

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Your Worry Free Migration to eTMF

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

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4 Reasons You’ll Be Happier When You Ban the Note to File

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

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How To: File a Certified Copy (and Leave Paper Behind)

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

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How To: How to Use E-Signatures

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

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Avoiding the Naughty List: Inspection Readiness at the 8th TMF Summit

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,

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LMK Remembers the 100th Anniversary of World War I

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

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How To: How to Decide When to Write a Note to File

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

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How To: Make Sense of an Unfamiliar 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

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How To: Determine on What TMF Level a Document Should Be Filed

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

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How To: Use the TMF Reference Model

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

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Surviving Protocol Amendments: Preparation is Key

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

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Diagnosing Double Vision

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

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Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC

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

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TOP 10 Things to do for DIA 2018 in Boston

Come meet LMK at booth 823 at DIA! We think it’s fitting that an event that will shape the future of the pharmaceutical industry is held in a city that is both entrenched in the history of our country and fully committed to the innovations of the future. Although LMK isn’t local to Boston, we

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Have More Than Faith: Have Conviction

A Message from Sholeh Ehdaivand President and CEO of LMK Clinical Research Consulting Sometimes when we are watching TV together, and an ad for a new drug comes on screen, my kids will ask, ‘Mom did you work on that?’ Sometimes I can say, yes I did! My first step as an entrepreneur was made

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Top 10 reasons to implement the TMF Reference Model

In anticipation of the release of version 3 of the TMF Reference Model and in honor of David Letterman’s last “Late Show” appearance, this post mimics his famous Top 10 list. Here are the Top 10 reasons to implement the TMF Reference Model. Enjoy! #10. You can finally answer the question “does this document belong

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Three Key Conclusions: New MHRA GCP Inspection Metrics

Great Britain’s MHRA (Medicines and Healthcare products Regulatory Agency) is known (and feared) for their high expectations regarding the TMF. MHRA expects your TMF to be “the story of how the trial was conducted and managed.” Their “inspectors want to reconstruct the trial conduct so that it can be evaluated for compliance …[and] review any

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A Series of Unfortunate Events… In the TMF

“No-one goes to work to do a bad job!” This quote, penned by legendary management thinker W. Edwards Deming, was introduced to us by a friend of LMK, process improvement and human factors guru, Keith Dorricott. In a recent LMK webinar, Keith discussed best practices for TMF metrics, and arrived at the conclusion that this

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Is Your TMF Ready For GDPR? Part Three: Know Your Responsibilities

Is your TMF ready for GDPR? This is the third and final post of a series examining how the new European Union General Data Protection Regulation could affect your trial master file. See part one and part two which examine the basic roles within GDPR and the foundational rights of data subjects. Serious Penalties and

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Bridging The ISF-TMF Divide: What Roles Should Sponsors & Investigators Play?

Regulation, more than just stipulating what must be done, must also define whose job it is to complete the task. The assignment of responsibility within the regulatory framework surrounding the clinical trial is essential to protecting the well-being of subjects and the validity of the trial’s data. Clear demarcation of the primary roles of sponsor

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Is Your TMF Ready For GDPR? Part Two: Know Your Rights

Is your TMF ready for GDPR? This post is the second article in a three-part series examining how the new European Union General Data Protection Regulation could affect your Trial Master File. In our last post on the European Union General Data Protection Regulation (GDPR) we examined the primary roles found within the regulatory framework

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Is Your TMF Ready For GDPR? Part One: Know Your Roles

This post is the first in a two-part series outlining how the new European Union General Data Protection regulation could impact your Trial Master File. Since 1995, EU Directive 95/46/EC has provided the foundation for “the protection of individuals with regard to the processing of personal data and on the free movement of such data”.

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The Silliest Thing We Can Imagine

Elon Musk decided to test his revolutionary Falcon Heavy rocket with the “silliest thing we can imagine”. Usually test payloads for new rockets are made of boring hunks of steel and concrete, but if Elon’s past actions are any indication –see his Boring Company branded flamethrower— normal just wouldn’t do. So Musk tweeted out this

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The Spirit of the Olympics in your TMF

The PyeongChang Olympics have begun with a flurry of inspiring headlines: Shaun White takes the gold medal and regains his crown’ Russian athletes allowed to compete despite doping controversy’ Unified Korean women’s hockey team takes the ice under united one flag’ These headlines give us hope that the Olympic Games reflects the best of humanity.

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Romance in the TMF

I bet you are familiar with those cliché candy hearts, but did know those little hearts share some history with the pharmaceutical industry? Conversation hearts were first invented in 1847, when Boston pharmacist Oliver Chase decided he wanted to make his fortune in the apothecary lozenge fad of the mid-1800s.  While Chase was working as

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TMF Summit 2018 – Top Three Trends

It was a pleasure attending this year’s TMF Summit for many reasons. Here are the top three trends in TMF that I noticed throughout the presentations: Focus on the TMF (Trial Master File) varies greatly by company. I was surprised to see that even some of the bigger companies in attendance have only made the

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TMF Game-Plan: Penalty Avoidance

No matter who you wanted to win the Super Bowl, we can all agree that the officiating of the game played an unusually large role in the outcome of this season. A series of key calls seemed to tilt the odds in favor of the Patriots—much to the frustration of everyone but Pats fans. The

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Staying out of the Ozarks: Financial Disclosure and the TMF

Up until the day everything changed, Marty thought he lived the perfect life. Marty had the wife, the colonial framed by a white picket fence, and two picture-perfect children. Marty was reserved, logical, and in control. Marty was a top earning financial advisor. Marty was awash in money. Unfortunately, Marty also washed money… for a

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What are your TMF Resolutions?

Why do we make resolutions? The idea of starting over with the New Year is an attractive one. After a long year, it’s human nature to detour into bad habits or lose sight of the incremental steps necessary to reach an important goal. But what are the resolutions we all have in common? Since we

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The Twelve Days of Quality Control (QC)

We know the Holidays can be a stressful time of the year. You and your team are doing their best to meet yearend goals while hanging up the lights and fighting mall traffic. We are happy to tell you that you’ve almost reached the finish line – happily, there are fewer than twelve days until

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Single Source of Truth: the Future of TMF Automation

Webinar Recap Sholeh Ehdaivand, CEO of LMK Consulting and Frederico Braga, principal of platform strategy and adoption at Medidata, recently spoke on a webinar how using technology such as Medidata Clinical Cloud can automate the management and creation of trial master files – accelerating processes such as study start-up for clinical ops and clinical IT.

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What We’re Thankful For This Year

For those of us in the North Carolina office, the frosty mornings of fall are finally upon us. We all know that at this time of year, if you blink, New Year’s Eve has already come and gone.  It’s the speedy arrival of the Holidays that causes us to reflect on how quickly things can

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The Zombie TMF

Happy Halloween from the team at LMK! We’ve been carving pumpkins, hoarding candy (some of which may survive for the trick-or-treaters), and shuffling along like zombies to Michael Jackson’s Thriller every time it pops up in our Halloween playlist. We know Halloween is scary for a lot of reasons, but realizing that the album Thriller

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Defeating your Demogorgon: TMF Inspection Readiness

This blog post is the continuation of our two-part Stranger Things series. Check out the first post, Your Way Out of the Upside Down: TMF QC. If you happen to be a big fan of Netflix’s hit show Stranger Things, you’ve definitely noticed the countdown to the season two premier ticking away on Netflix’s home

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Your Way Out of the Upside Down: TMF QC

The season two premier of Netflix’s hit show, Stranger Things, is less than two weeks away. Since we’re big fans here at LMK, we’ve been preparing a lot like you have: by re-watching episodes, obsessing over the new trailer, and daydreaming about what season two will hold. But at LMK, we aren’t just your normal

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Informed Consent: The Story Your TMF Needs to Tell

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.

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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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

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eTMF 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

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To Migrate or Not to Migrate? That is the Question

You have a shiny new eTMF technology with all of the bells and whistles that you and your team thought would only be possible in your dreams!  Finally, TMF documents can be loaded without a second thought to inspection readiness because this new system provides instant access on your computer screen to what is present

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Veeva 2016 Paperless TMF Survey

At the 2016 Drug Information Association (DIA) conference in Philadelphia a few weeks ago, Veeva released the third annual Veeva 2016 Paperless TMF Survey. The goal of this 13-question Survey (many of which included sub-questions with response matrices) was to further understand the impact of the electronic TMF (eTMF) adoption on clinical processes and the

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TMF Quality Control or TMF Inventory: What’s the Difference?

Over the years, I have participated in and managed a number of TMF Quality Control (QC) projects, and it has become one of my favorite activities. It’s one of the reasons I am facilitating the Metrics Champion Consortium (MCC) initiative on the TMF and leading the quality work stream for the TMF Reference Model. One

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Five Reasons Why TMF Training is Important

Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF). Perhaps that’s why, according to a recent article in Forbes magazine, US companies spent over $70 billion on corporate training in 2014, an increase of 15%

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Mergers, Acquisitions (M&A) and the TMF?…Oh My!

It seems that every time I open my MSNBC app, I read about yet another pharma/biotech merger and acquisition (M&A).  What exactly is an M&A anyway?  Investopedia defines a merger as “a combination of two companies to form a new company, and an acquisition as the purchase of one company by another.” My favorite is

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5 Pillars of the Trial Master File (TMF)

To build a strong TMF that is not only inspection ready at all times, but also reliable and credible is essential for the reconstruction of the conduct of any clinical trial during an audit or inspection process. The following 5 pillars of TMF success facilitate efficient trial management: 1. Standardized processes: There’s more than one

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Before you write that Note to File (NTF), read this!

This post is unconventional and perhaps a little unpopular, but it has to be said: more than likely, you are writing and filing TOO many NTFs for missing documents, signatures, and data. Enough is enough!   Carl Anderson said it best in his article from March 1, 2008 in Applied Clinical Trials, “The practice has become so ubiquitous that new

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2015 TMF Survey Yields Interesting Results

The Trial Master File Reference Model (TMF RM) team conducted the fifth annual TMF RM Survey from May to July 2015. The survey results were published last week and I would like to share with you some very interesting data about current TMF practices. SURVEY BACKGROUND As a sub-committee member of the TMF RM initiative,

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Is Your TMF “Fit”?

Effectively Operationalizing your Trial Master File Requires the human element. Like so many of you, I really love my Fit Bit. Nothing gives me more satisfaction then to see the counter turn to 10,000 each and every day. Unfortunately, the counter does not turn by itself. In order to reach my 10,000 step-a-day goal, I

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