Just in Time GCP Named Among Top Women-Owned Businesses & Inc. 5000 Just in Time GCP, a women-owned clinical research company specializing in GCP compliance, is proud to announce dual recognition in 2024: Ranked #9 on the Philadelphia Business Journal’s list of the Largest Women-Owned Businesses in Greater Philadelphia. Named to the Inc. 5000 list […]
Just in Time GCP Appoints Aaron Grant as Head of Innovation to Advance Clinical Trial and TMF Innovation Just in Time GCP is excited to welcome Aaron Grant as our new Head of Innovation. This newly created role will accelerate clinical trial innovation and help sponsors strengthen TMF quality, inspection readiness, and compliance. Aaron brings […]
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“Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry” is a draft guidance document issued by the FDA in June of this year.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 […]
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 […]