Just in Time GCP once again makes the INC5000 list ranking No. 2813

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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Navigating Good Clinical Practice Compliance in Clinical Trials

Navigating Good Clinical Practice Compliance in Clinical Trials In the realm of clinical trials, ensuring the safety, rights, and well-being of participants is paramount. This is where Good Clinical Practice (GCP) comes into play. Compliance with GCP is essential for conducting ethical and scientifically sound clinical research, and it is a fundamental requirement for regulatory approvals across the globe, including by the FDA, EMA, MHRA, and PMDA. Navigating GCP compliance can be challenging for those organizing clinical trials. However, a greater understanding of GCP is the first step toward ensuring

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How to Prepare an Inspection-Ready Trial Master File

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 quality check (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

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5 Ways An External Vendor Can Support Your GCP Compliance Program

Ensuring Good Clinical Practice (GCP) compliance is paramount for any organization involved in clinical trials. It ensures the safety, rights, and well-being of trial participants while maintaining data integrity. Leveraging the expertise of external vendors can significantly bolster your GCP compliance program. Here are five critical areas where an external vendor can make a substantial impact. Clinical GCP Quality Management System Assessment A comprehensive Clinical GCP Quality Management System (QMS) is the foundation of a robust compliance program. An external vendor can offer an objective assessment of your current QMS,

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Driving Innovation in Clinical Trials: Trends for the Future

In the dynamic landscape of clinical trials, innovation isn’t just a buzzword; it’s the cornerstone of progress. It can be difficult to identify where to focus innovation efforts when technology is changing at an exponential rate, business needs continue to shift, and regulations provide new roads to traverse. As we peer into the crystal ball of tomorrow, here are some transformative trends we believe will redefine the way trials are conducted, data is managed, and patient outcomes are improved.   AI-Powered Predictive Analytics:   Artificial Intelligence (AI) is already here

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Just In Time GCP’s Key Takeaways from CDISC EU Interchange

CDISC EU Interchange 2024 has concluded and this year we were offered a treasure trove of insights and innovations. The TMF Reference Model’s inclusion in CDISC has further solidified the driving trend of data standardization and interoperability of TMFs. While I enjoyed presenting with Arkivum’s Matthew Addis and seeing fellow JiT representative Carol Radwanski present with inSeption Group’s Dawn Niccum, the reality is that our presentations represented a small sample of the vast expanse of information there was to learn. With several tracks available and multiple sessions running in parallel,

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Practical Insights and Tools for Change Management

We have established throughout this blog series that change is inevitable in any organization. Whether it’s implementing new technology, restructuring processes, or adapting to market trends, change is a constant force that requires effective management to ensure and sustain success. In our final blog, we’ll explore practical insights and summarize the key tools  Just in Time uses in their change management methodology, drawing from real-life applications and lessons learned from the field.   Practical Tools for Change Management Change management involves a structured approach to transitioning individuals, teams, and organizations

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