Just In Time GCP is excited to announce the promotion of Ashely Bates to the position of Senior Director of Operations. In this new capacity, Bates will be responsible for leading the operational functions of the company and contribute to establishing and implementing the corporate strategy and core values by serving on the Executive team. […]
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 […]
Inspection site preparations are stressful for everyone involved. Clinical trials are challenging, and they take on a life of their own at each clinical site. Are you ready to have a regulator look into your documentation? Sometimes you think you have everything covered, but a fresh set of eyes may uncover things you did not […]
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 […]
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 […]
WARRINGTON, PA., AUGUST 18, 2021 – Inc. magazine today revealed that Just in Time GCP is No. 774 on its annual Inc. 5000 list, the most prestigious ranking of the nation’s fastest-growing private companies. The list represents a unique look at the most successful companies within the American economy’s most dynamic segment—its independent small businesses. “We […]
The Trial Master File is a window into the study through all phases of drug development. The TMF is comprised of the records that tell the story of your study. It gives evidence that the trial was conducted in alliance with standards of Good Clinical Practice (GCP). This story becomes the cornerstone of inspection readiness. […]
There are different types of quality checks performed on TMF content. Uploaders should perform a record quality check prior to uploading a record. Records should go through some type of QC workflow post upload. Additionally, there should be periodic risk based completeness checks of the TMF through-out the life of the study. Finally, an Inspection […]
