Artificial Intelligence (AI) has been making significant strides across various industries, and clinical operations are no exception. The integration of AI technologies is transforming how clinical research trials are designed, managed, and executed, leading to enhanced efficiency, reduced costs, and improved outcomes. Let’s explore the profound impact of AI on the clinical operations industry, with […]
In the realm of clinical trials, maintaining comprehensive and accurate documentation is not just a regulatory requirement but a cornerstone of ethical and effective research. Recently, the Medicines and Healthcare products Regulatory Agency (MHRA) issued an Infringement Notice to Celixir for significant deficiencies in trial oversight, including a glaring lack of sponsor Trial Master File […]
The Trial Master File (TMF) is a collection of essential documents that tells the story of a clinical trial and provides evidence that the study was compliant with Good Clinical Practice (GCP) standards. TMF inspection readiness ensures that all trial documents are complete, organized, and easily accessible, which is vital for regulatory compliance and the […]
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 […]
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 […]
