“Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry” is a draft guidance document issued by the FDA in June of this year. The intent is to provide clarity on the procedures and practices related to Bioresearch Monitoring (BIMO) inspections. This document is designed to help industry stakeholders understand what to expect during FDA inspections of sites and facilities involved in FDA-regulated research, ensuring compliance with statutory requirements and safeguarding the integrity of data and the welfare of clinical trial participants. It provides critical insights for industry stakeholders

Just in Time GCP is proud to announce its inclusion on the 2024 Inc. 5000 list, marking the fourth consecutive year the company has been recognized among America’s fastest-growing private companies.  “This achievement is a testament to the hard work the incredible JIT GCP Team has put in over the past several years, and the remarkable journey we are taking together.” says Founder & CEO Donna Dorozinsky.   The Inc. 5000 list is a prestigious ranking that highlights the most successful independent businesses in the U.S. The 2024 list showcases

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. It serves to protect the rights, integrity, and confidentiality of trial subjects. Ensuring compliance with GCP principles is crucial in clinical trials. This article will highlight four key reasons why following GCP compliance principles is essential. 1. Protects the Human Subject Compliance with GCP ensures that clinical research trials are conducted ethically, with informed consent from participants and appropriate oversight. Explanation Ethical conduct in

To effectively manage the Trial Master File (TMF), it is essential to track and monitor key metrics or Key Performance Indicators (KPIs) that measure the completeness, timeliness, accuracy, accessibility, and compliance of the TMF with regulatory guidelines. Monitoring these metrics ensures the TMF is always inspection-ready, facilitating smooth regulatory reviews and demonstrating thorough oversight of the clinical trial processes. Why Are TMF Metrics Important? Monitoring TMF metrics provides crucial insights into various aspects of clinical trial management. These metrics can be pivotal during inspections to demonstrate the following: Inspection Readiness:

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 specific examples related to clinical trial activities. 1. Enhanced Data Analysis and Interpretation The volume of data generated in clinical trials is enormous. AI excels in handling big data, identifying patterns, and making sense of

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 (TMF). This incident serves as a stark reminder of the crucial role that sponsor TMF plays in the integrity of clinical trials and the reflection of sponsor oversight activities. The MHRA Infringement Notice: A Wake-Up