About Just In Time GCP
With a passion for driving inspection readiness and GCP compliance, we turn operational challenges into operations excellence.
Through our experience and knowledge, we offer high-quality services and always deliver on our promise to ensure accuracy and compliance.
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Our focus on the TMF results in quality and complete TMFs.
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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 make you feel a bit uneasy? Let us help your team get prepared! Don’t have an upcoming inspection, but have gaps in your inspection preparedness activities and processes? Now is the time to work toward
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you think you have everything covered, but a fresh set of eyes may uncover things you did not notice: missing or outdated trainings, missing communication to explain an adverse event, missing versions of protocols, pharmacy manuals, IP temperature logs to name a few. Preparing for inspections is not just about the Sponsor or
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 these updates on their business processes. As part of a regulatory compliant change management, it is critical that each change be assessed from not only a systems impact, but also a process impact. When receiving
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 document and overall completeness level. When we look at the completeness of the TMF it is generally based on an expected set of documents relevant to the milestones of the study. These expectations are built
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 are thrilled to be recognized by Inc. magazine for our tremendous growth as an organization. It is a validation of all the efforts we have made on behalf of our pharmaceutical and biotech clients to
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. The purpose of a regulatory inspection is to confirm that the study was conducted in compliance with GCP, confirm the integrity of the data, and ensure human subject protection. How do we use the power