Blogs Case Studies White Papers

LMK Blogs

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

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

Read More »

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

Read More »

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

Read More »

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

Read More »

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”.

Read More »

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

Read More »

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.

Read More »

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

Read More »

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

Read More »

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

Read More »

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

Read More »

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

Read More »

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

Read More »

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.

Read More »

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

Read More »

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

Read More »

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

Read More »

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

Read More »

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?

Read More »

Request a complimentary consultation.