Blog Posts

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…

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…

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…

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.…

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…

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…