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 […]
There are different types of quality checks performed on TMF content. Uploaders should perform a record quality check prior to uploading a record. Records should go through some type of quality check (QC) workflow post upload. Additionally, there should be periodic risk based completeness checks of the TMF through-out the life of the study. Finally, […]
