About Just In Time GCP
With a passion for driving inspection readiness and GCP compliance, we turn operational challenges into operations excellence.
Through our experience and knowledge, we offer high-quality services and always deliver on our promise to ensure accuracy and compliance.
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Our focus on the TMF results in quality and complete TMFs.
Industry News & Resources
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Highlights from Barnett International’s “Good Clinical Practice A Question & Answer Reference Guide”
What is a Trial Master File (TMF)? The TMF is a standalone collection of records that tells the story of the clinical trial in its entirety. It is composed of a set of records held by the sponsor organization and an investigator TMF held by the investigation/institution, often called the Investigator Site File (ISF). Both the sponsor TMF and the investigator/site TMF are established at the start of the study. It is important that the sponsor and investigator/institution TMFs are maintained separately and the institution/investigator should maintain control of their
In the dynamic realm of clinical research, the partnership between Just in Time GCP (JiT) and fme emerges as a beacon of innovation, particularly with their recent unveiling of CROAssist. This collaboration is not just a merging of two entities; it’s a fusion of expertise and technology to redefine the landscape of Trial Master File (TMF) management in clinical trials. The inception of CROAssist™ is a testament to the forward-thinking approach of both JiT and fme. JiT brings to the table its unparalleled expertise in risk-based TMF management approaches, which
We are thrilled to announce that Ashley Bates has transitioned into the role of Sr. Director Consulting & Partnerships. In this role, Bates will leverage her strength in building relationships to lead the continued growth of Just in Time GCP’s consulting practice. She will also be responsible for expanding partnerships to build alliances with organizations that complement the work at Just in Time GCP with a focus on embedding innovation into our service offerings. “I am honored to lead an exceptional group of consultants at Just in Time GCP, and
We are thrilled to announce that Brian Guza has joined the company as Chief Operating Officer. In his role, Guza will be responsible for leading the execution of the strategic vision and growing the organization’s presence in the industry. A seasoned healthcare executive with nearly three decades of experience in healthcare operations, strategic planning, technology, and executive leadership, Guza brings his unique pharma service partner experience and insights to help empower Just in Time GCP to serve its clients and shape the future of Clinical technology consulting and service delivery
What an amazing few days of learning and collaboration during the inaugural CDISC TMF Interchange last week. Special thanks to the speakers and panelists for their informative and thoughtful comments. If you missed it, here are some key takeaways: We’re all in this together! Companies large and small are experiencing many of the same challenges within the TMF space. Working in conjunction with CDISC, we’re making the Reference Model an industry standard, providing clarity and alignment. Standardization Goals Organizations like TransCelerate are paving the way for standardization via protocol templates, etc.
This past week Just in Time GCP participated in Veeva’s 2023 R&D summit in Boston as a Gold Sponsor. It was an incredible opportunity to meet and talk with other partners and users of the Veeva Platform. Veeva hosted thought-provoking sessions where industry leaders shared their experience leveraging Veeva product suites to streamline their own internal processes and push clinical research forward. The product roadmaps shared by Veeva created excitement around the future of technology in this space and got people talking. In the Innovation Hub, a plethora of learning