Ensuring Your Operations Support Your Trial’s Scope Moderating a recent roundtable discussion on clinical process assessment has highlighted a growing gap between current clinical process capabilities and the requirements needed to execute complex studies. A comprehensive assessment of clinical processes, systems, and infrastructure is essential to ensure they align with both regulatory requirements to ensure […]
The Importance of TMF Management in Clinical Quality Just in Time GCP’s Founder and CEO, Donna Dorozinsky, shared her expertise in a recent article in The Clinical Trial Vanguard titled The Trial Master File: A Window into the Quality of Any Clinical Study. This article highlights the essential role of the Trial Master File (TMF) […]
Just In Time GCP: Recognized for Impact and Innovation in Clinical Research Just In Time GCP is excited to announce our recognition as #9 on the Philadelphia Business Journal’s 2024 Largest Women-Owned Businesses in Greater Philadelphia. This prestigious accolade underscores our commitment to excellence and innovation within the clinical research industry. Additionally, we are thrilled […]
Just in Time GCP is thrilled to announce the appointment of Aaron Grant as the new Head of Innovation, a newly created position designed to drive change within the clinical research industry. With a strong passion for industry transformation and a commitment to excellence, Aaron brings extensive experience and a forward-thinking mindset to the Just […]
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 2024. […]
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“Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry” is a draft guidance document issued by the FDA in June of this year.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, a company focused on enhancing the quality of clinical trials, 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 […]
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 […]
