The Just in Time GCP Team At Just in Time GCP (JiT), our team members are integral to our mission of delivering top-tier GCP compliance and clinical research consulting services. This month, we’re shining the spotlight on one of ours, Ralf Brooks, who joined the JiT Team just four months ago, in July of […]
Insights from the 2024 Veeva R&D Summit Last week the Just in Time GCP team attended the Veeva R&D Summit in Boston where we proudly served as a Gold Sponsor. Veeva Summit was an exciting experience which provided an opportunity for attendees to engage with Veeva experts, partners, and users. It also offered a glimpse […]
“Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry” is a draft guidance document issued by the FDA in June of this year.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 […]
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 […]
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 […]
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 […]
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 […]
