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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