Category: Uncategorized

Highlights from Barnett International’s “Good Clinical Practice A Question & Answer Reference Guide”

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 […]

Seamless Integration: Transforming CRO to Sponsor Data Transfers with JiT and fme

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 […]

Just In Time GCP’s Key Takeaways from CDISC TMF Interchange

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

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 […]

For the 3rd Year in a Row, Just in Time GCP Makes the Inc. 5000, Ranking No. 2813

PHILADELPHIA, August 16, 2023 (Newswire.com) – Inc. revealed today that Just in Time GCP ranks No. 2813 on the 2023 Inc. 5000, its annual list of the fastest-growing private companies in America. The prestigious ranking provides a data-driven look at the most successful companies within the economy’s most dynamic segment—its independent, entrepreneurial businesses. Facebook, Chobani, Under […]

Right-sizing a Clinical Compliance Program

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 […]

An Inspection Ready versus Inspection Prepared TMF

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 […]

Taking the Stress Out of Inspection Readiness

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 Systems Updated

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 […]

Is Your Organization Inspection Prepared?

We hear so much about organizations having an inspection ready TMF at all times; but is an inspection ready TMF truly enough?  An inspection ready TMF is defined as the TMF being of quality and complete based on the milestones of the study.  We achieve this through ongoing review of the TMF at both the […]