Blog Posts

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

TMF Transformation: A Guide to Sustainable Process Development

June 13, 2023

Sustainable TMF processes are vital for the success of clinical trials. A well-designed, stable, and scalable TMF process brings numerous advantages, such as increased efficiency, reduced compliance risks, and improved data integrity. On the other hand, poorly defined and constantly changing TMF processes can be time-consuming, introduce compliance risks, and hinder progress towards TMF goals.…

Read More

Calling All TMF Champions

May 30, 2023

Welcome to the TMF Champions Blog Series. In celebration of Trial Interactive’s fifteen-year anniversary, and in collaboration with Transperfect, we will be bringing you insights from long-time industry experts to help you build a culture of inspection readiness and pursue TMF Champions in your organization. We’re excited to dive deep into what makes a TMF…

Read More

Decoding Double Vision

May 25, 2023

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…

Read More

The Evolution and Continued Success of TMF University

May 18, 2023

LMK recognized a void in the area of educational excellence and regulatory knowledge surrounding the management of the TMF in the clinical trial space. While there are many webinars and conferences related to TMF, most provide only foundational knowledge and do not equip attendees with the skills and behaviors to operationalize TMF management. This void led…

Read More