Carol Wiley

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 […]

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 […]

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 […]

Overcoming Resistance and Engaging Stakeholders

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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

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 […]