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I noted a compliance concern about two years ago with our trial master files and looked around the industry for help. Just in Time GCP was recommended as a specialist in fixing TMF compliance issues. Over the last two years working with the team, we formulated a plan for migrating and transferring our TMF’s into one system and now we have validated and updated this system. Together, we created TMF maps, plans, process and training. Donna and her team fit into our company. They worked tirelessly and as a result, we sailed through our last Health Authority inspection.

Just in Time was instrumental in helping us achieve two successful mock FDA inspections. The team came helped us perform a gap analysis on our study TMFs, created storyboards, and prepped all SMEs. They even audited sites. Every detail was covered - even down to which conference rooms we would use for inspection day and how many reams of paper we would need to have on hand.

News You Can Use

A Year of Growth and Industry Recognition

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 to be included in the 2024 Inc. 5000 list for America’s Fastest Growing Private Companies for the fourth consecutive year. This recognition not only highlights our rapid growth but also reaffirms our commitment to fostering

Welcome Aaron Grant as Head of Innovation

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 in Time GCP team. Must Consistently Raise Standards to Drive Excellence “Just in Time GCP is a highly regarded authority on best practices in clinical research; however, it’s essential to recognize that the definition of

Employee Spotlight – Ralf Brooks

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. Ralf’s expertise in Good Clinical Practice (GCP) compliance, quality management systems, and clinical research continues to enhance our clients’ success. Why did you decide to work at Just in Time GCP? “I joined JiT

Insights from the 2024 Veeva R&D and Quality Summit

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 into the future of Veeva’s innovations and the evolving landscape of clinical operations. A recurring theme of this year’s summit was to ‘Simplify and Standardize’. Veeva leaders shared their vision of how we can achieve

The Recent FDA Draft Guidance on Processes & Practices Applicable to a BIMO Inspection

“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 Celebrates Its Fourth Consecutive Year on the Inc. 5000 List!

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