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 […]
Throughout this series we have established that change is inevitable in any organization striving for growth and adaptation. However, with change comes resistance, often stemming from uncertainty, fear, or a reluctance to stray from the familiar. As leaders and change agents, it is imperative to understand the dynamics of resistance and effectively engage stakeholders to […]
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 […]
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 […]
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 […]
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 […]
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 […]
What an amazing few days of learning and collaboration during the inaugural CDISC TMF Interchange last week. Special thanks to the speakers and panelists for their informative and thoughtful comments. If you missed it, here are some key takeaways: We’re all in this together! Companies large and small are experiencing many of the same challenges within […]
In the last 2 years at JiT I have been a part of various system implementations in many ways. I have been part of the vendor selection process, the sponsor/lead, the SME, supported migration loaders, performed validation activities, and of course I’m an end-user. So, from all those various roles and experiences in my past, […]
PHILADELPHIA, August 16, 2023 (Newswire.com) – Inc. revealed today that Just in Time GCP ranks No. 2813 on the 2023 Inc. 5000, its annual list of the fastest-growing private companies in America. The prestigious ranking provides a data-driven look at the most successful companies within the economy’s most dynamic segment—its independent, entrepreneurial businesses. Facebook, Chobani, Under […]
