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.

From Our Customers

Our focus on the TMF results in quality and complete TMFs.

Industry News & Resources

News You Can Use

How a Strong Trial Master File Helps In Asset Divestitures

Considerations in acquisitions of pharma and biotech organizations and their assets are multifaceted and involve various factors, including financial, strategic, regulatory, and operational aspects. One often overlooked operational aspect is the Trial Master File (TMF). An organization that is looking to be acquired or have an asset acquired will add value by having well organized and complete TMFs to support their studies.  Conversely, an organization looking to acquire an asset or company, paying attention to the quality of the TMF should be considered a critical element of due diligence and

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Navigating Change: The 3-Stage Change Management Process

Change is inevitable, especially in today’s fast-paced and dynamic world. Whether it’s implementing new technology or restructuring processes, organizations must effectively manage change to thrive and remain competitive. However, change can be disruptive and challenging to navigate without a clear strategy in place. This is where change management comes into play—a structured approach to transitioning individuals, teams, and organizations from their current state to a desired future state.   In this blog, we’ll explore Just in Time GCP’s 3-stage change management process, breaking down each stage, discussing key activities, challenges,

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Understanding the Need for Change Management

In the clinical trial landscape, where innovation and adaptation are paramount, understanding the need for change management is crucial for success. Change management is a structured approach to transitioning individuals, teams, and organizations from their current state to a desired future state. It enables employees to effectively adopt and retain change.   Embracing change is imperative in clinical trials to enhance efficiency, comply with evolving regulations, and integrate innovative technologies. While, resisting change can lead to project delays, increased risk or costs, and may jeopardize the success of trials. This

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Highlights from Barnett International’s “Good Clinical Practice A Question & Answer Reference Guide”

What is a Trial Master File (TMF)? The TMF is a standalone collection of records that tells the story of the clinical trial in its entirety.  It is composed of a set of records held by the sponsor organization and an investigator TMF held by the investigation/institution, often called the Investigator Site File (ISF).  Both the sponsor TMF and the investigator/site TMF are established at the start of the study.  It is important that the sponsor and investigator/institution TMFs are maintained separately and the institution/investigator should maintain control of their

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Seamless Integration: Transforming CRO to Sponsor Data Transfers with JiT and fme

In the dynamic realm of clinical research, the partnership between Just in Time GCP (JiT) and fme emerges as a beacon of innovation, particularly with their recent unveiling of CROAssist. This collaboration is not just a merging of two entities; it’s a fusion of expertise and technology to redefine the landscape of Trial Master File (TMF) management in clinical trials. The inception of CROAssist™ is a testament to the forward-thinking approach of both JiT and fme. JiT brings to the table its unparalleled expertise in risk-based TMF management approaches, which

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Just in Time GCP Announces New Leadership for Consulting & Partnership Programs

We are thrilled to announce that Ashley Bates has transitioned into the role of Sr. Director Consulting & Partnerships. In this role, Bates will leverage her strength in building relationships to lead the continued growth of Just in Time GCP’s consulting practice. She will also be responsible for expanding partnerships to build alliances with organizations that complement the work at Just in Time GCP with a focus on embedding innovation into our service offerings. “I am honored to lead an exceptional group of consultants at Just in Time GCP, and

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Recognitions