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 […]
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 […]
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 […]
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 […]
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 […]
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 Management Preparing, Managing, and Sustaining Organizational Change 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 […]
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 […]
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 […]