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,

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

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 ensure successful transitions. In this blog, we’ll explore the nuances of overcoming resistance and engaging stakeholders throughout the change process (not just at the end).   Understanding Resistance Resistance to change is a natural human

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

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,

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