Get the latest updates from the LMK Clinical Research Team! New blogs are released periodically throughout the year.
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
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.
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
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
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
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
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?
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
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
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
On Sunday evening, millions tuned in to watch the team everyone loves to hate (the New England Patriots, of course) make their ninth Super Bowl appearance in a 1:1 match-up against the Atlanta Falcons. For the first three quarters, it seemed as if the Falcons had “risen” and were on their way to take home
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
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
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
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%
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
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
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
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,
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