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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Just in Time GCP is thrilled to announce that Marion Mays has joined our organization as Vice President Inspection Readiness. In this role Marion will continue to grow the JiT services related to supporting clients in their efforts to become fully inspection prepared. Marion will combine her extensive TMF and GCP inspection experience as a subject matter expert in meeting the needs of our growing client base. Marion brings to JiT a career of experience in pharma, CRO, and technology organizations. President & CEO, Donna Dorozinsky shares “I have had the privilege of working
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
Jamie O’Keefe has joined the leadership team at Just in Time GCP as Vice President Business & Technology Consulting. Jamie comes to Just in Time GCP with almost 20 years of life sciences experience in both sponsor and consulting organizations. He is a business domain expert with deep experience in the Life Sciences and IT fields underpinned by operational excellence and management capabilities. He is an expert in process optimization, regulatory operations, and clinical operations. Jamie is recognized as an exceptional and caring leader with an uncanny talent for quickly
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 Readiness review may be indicated for some studies. This concept of an inspection ready TMF can be overwhelming at times and certainly can appear resource intensive if not adequately defined and to some degree based