One of the fundamental principles in Trial Master File (TMF) management is to prevent the duplication of documents. We all recognize that the primary objectives of the TMF are to meticulously document the clinical trial process and safeguard the rights of patients. Equally important is the TMF’s role in facilitating, rather than hindering, the audit…

You’ve gone through the steps. You know the rhythms. The familiar routines. Get everything in its rightful place. It’s imperative to start off on the right foot and to keep the process moving at the right pace. It’s not always exciting, but it’s crucially important to achieve the end result you desire. The Trial Master…

How did you get into the clinical research industry and what career path did you take? I didn’t take the most obvious route! I was actually working in insurance, but really not enjoying it. One day I was talking to a friend who worked for a CRO and I became very interested in what they…

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…