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 in a small pharmaceutical company requires careful consideration and strategic planning. While the specific details will depend on the size and nature of your organization, there are some general steps to help you right-size your clinical compliance program. Start with the basics by familiarizing yourself with the applicable regulations and […]
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 […]
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 […]
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 […]
