Blog Posts

From Feasts to Files: Thanksgiving Traditions and TMF Standards

November 21, 2023

As the crisp, frost-kissed mornings of autumn embrace us, the passage of time seems to accelerate. In the blink of an eye, we transition from fall’s embrace to the glittering threshold of New Year’s Eve. This swift journey through the holidays prompts a moment of reflection on the fluid nature of life. It’s not just…

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Narrative Dynamics in Clinical Trials: Weaving Integrity into TMF Management

November 16, 2023

In the complex landscape of clinical trial management, an increasing emphasis has been placed on the utilization of quantitative metrics to gauge the effectiveness of trial master file (TMF) operations. These metrics are derived from the advanced reporting capabilities of electronic TMF systems and are intended to capitalize on the data generated by contemporary clinical…

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Embracing Change: Mapping Your Successful TMF Migration Journey

October 2, 2023

Embracing change can be challenging. If your current TMF system no longer serves your team’s objectives, the thought of transitioning to a new eTMF system might seem daunting. However, picking the right eTMF system is just the starting point. The implementation phase involves training, updated SOPs, thorough QC of your existing TMF, and possibly manual…

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The Evolution and Significance of Informed Consent in Clinical Trials

October 2, 2023

The Complexity and Historical Markers of Informed Consent Informed consent stands as the cornerstone of ethical medical research. It has been shaped by time, events, and shifts in societal values, ensuring patients’ rights and well-being are at the forefront of any clinical study. But what moments in history truly defined its modern-day form? The Yellow…

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TMF University & IAOCR: Collaborative Leadership in Trial Master File Excellence

September 27, 2023

In an era defined by cutting-edge advancements in the realm of clinical trials, the Trial Master File (TMF) remains a cornerstone for ensuring that these trials are conducted ethically and in adherence to the rigorous standards set by global regulatory bodies. Amidst this landscape, LMK, with its pioneering vision, noticed a significant chasm in the…

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Preparing for Clinical Trials: The Intersection of Seasons, Football, and the CDISC Interchange Conference

September 18, 2023

As the leaves don a spectrum of amber and russet, the air takes on a brisk embrace, and the signature aroma of fall emerges, heralding a time of rejuvenation. The languid days of summer yield to autumn’s vibrant cadence. This transition isn’t merely a shift in seasons, but a testament to life’s cyclical nature. The…

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5 Skills for Cultivating a Culture of Excellence in TMF Management

July 25, 2023

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 clinical research’s explosive growth and complexity. The consequences of this skills gap are far-reaching, with the rising occurrence of TMF-related inspection findings posing a significant threat to patient access to…

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TMF Excellence in the Face of Protocol Amendments

June 29, 2023

Managing a Trial Master File (TMF) presents a myriad of challenges, and among them, grappling with a high number of protocol amendments emerges as one of the most formidable tasks. With each new amendment, there arises a crucial need to produce, track, and file all the documents that have undergone changes in tandem with the…

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Mindfulness in Clinical Operations: Building a Resilient and High-Functioning TMF

June 22, 2023

Feelings of anxiety wash over you. Your heart races as you receive the news. You wish for more time to prepare and consider working through the night. It’s TMF inspection day, and any meaningful changes now seem out of reach. TMF stress has long plagued the domain of clinical operations, making clinical documentation one of…

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