What is a Trial Master File (TMF)? The Trial Master File is a standalone collection of records that tells the story of the clinical trial in its entirety. It is composed of a set of records held by the sponsor organization and an investigator TMF held by the investigation/institution, often called the Investigator Site File […]
In the dynamic realm of clinical research, the partnership between Just in Time GCP (JiT) and fme emerges as a beacon of innovation, particularly with their recent unveiling of CROAssist. This collaboration is not just a merging of two entities; it’s a fusion of expertise and technology to redefine the landscape of Trial Master File […]
What an amazing few days of learning and collaboration during the inaugural CDISC TMF Interchange last week. Special thanks to the speakers and panelists for their informative and thoughtful comments. If you missed it, here are some key takeaways: We’re all in this together! Companies large and small are experiencing many of the same challenges within […]
Five Key Elements for a Successful Systems Implementation Over the past two years at JiT, I have contributed to numerous system implementations in various capacities. I have been involved in the vendor selection process, acted as the sponsor/lead, served as the SME, supported migration loaders, conducted validation activities, and, naturally, used the systems as an […]
Navigating the intricacies of clinical compliance in a small pharmaceutical or biotech company demands meticulous planning and strategic thinking. Although the particulars vary based on your organization’s size and business model, there are fundamental steps to help tailor your clinical compliance program effectively. Grasp the Regulatory Landscape: Begin by acquainting yourself with the relevant regulations […]
I am so ready for a vacation! How many of us have said that daily – ready for and desperately needing a getaway. It is easy to say we are ready for vacation, but would we be prepared for a vacation if it was offered on short notice? Being ready and excited for a vacation […]
Have you ever thought about how your team may interact with a regulator? Is your team prepared to speak about study events, including their responsibilities and contributions to study activities? Does everyone who may be called upon during an inspection know where to find information that supports the evidence of study activities? Do these questions […]
Managing the Impact of eClinical System Updates Many of us use cloud-based clinical systems that regularly release system updates. Sometimes these are optional updates and sometimes they are required. System updates do everything from fixing bugs to offering enhanced capabilities. Often organizations go through the motions of accepting these updates without considering the implication of […]
