When managing a clinical trial, the Trial Master File (TMF) plays a critical role in ensuring the trial’s success. To effectively manage the TMF, it is essential to track and monitor key metrics and KPIs that measure the completeness, accuracy, accessibility, and compliance of the TMF with regulatory guidelines. There are several key metrics and…

A breakup can be painful—especially around Valentine’s Day. Unfortunately, it happens enough that February 13th has gained the unofficial moniker of National Breakup Day. The day got that nickname when a study commissioned by Virgin Mobile concluded that 59% of survey respondents would purposefully break up with someone just before Valentine’s Day to save cash…

Concluding the whirlwind of 2022, it’s tempting to rush to make new resolutions, adopt new ideas, and embrace new goals. But before you do, it’s important to take some time to reflect. After all, we’ve accomplished so much in the past year—and so has the TMF. More than in the past, 2022 was a year…

As a TMF professional have you ever struggled to explain to others that your job isn’t simply filing paperwork? When managing a TMF have you ever been forced to use a software platform that is no longer fit for purpose but permanently entrenched in a critical business process? Have you ever attended an eTMF platform…

Skill #3: How to Evaluate Form FDA 1572 The life sciences industry faces a serious problem—a widespread trial master file (TMF) skills gap. There are simply not enough skilled TMF professionals to support the explosive growth and complexity of clinical research. That’s where LMK Clinical Research Consulting’s TMF University comes in. LMK’s TMF University is…

Skill #2: How to Perform Document Level QC The life sciences industry faces a serious problem—a widespread trial master file (TMF) skills gap. There are simply not enough skilled TMF professionals to support the explosive growth and complexity of clinical research. That’s where LMK Clinical Research Consulting’s TMF University comes in. LMK’s TMF University is…

Skill #1: How to Complete The Cycle of TMF QC The life sciences industry faces a serious problem—a widespread trial master file (TMF) skills gap. There are simply not enough skilled TMF professionals to support the explosive growth and complexity of clinical research. The result of this skills gap is the rising incidence of TMF-related…

The Netflix series Stranger Things is known for showcasing 80s’ films, pop culture, science fiction, and horror—all with a generous sprinkling of Dungeons and Dragons. Most of all, Stranger Things is known for its monsters: the Demogorgon, a demon with a mouth as its face; the Mind Flayer, a skyscraper-sized, spider-like monster comprised of darkness…

On Thursday, June 16th, Ben Rogers, Manager of TMF Education & Employee Development at LMK Clinical Research Consulting, shared LMK’s most powerful tool for aspiring TMF experts. We are, of course, talking about TMF University. Check out the recording here TMF University Town Hall, where Ben will answer your questions about LMK’s TMF University, the…