Category: Uncategorized

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 […]

Seamless Integration: Transforming CRO to Sponsor Data Transfers with JiT and fme

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 […]

Just in Time GCP Announces New Leadership for Consulting & Partnership Programs

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 […]

Just in Time GCP Announces Brian Guza as COO

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, […]

Just In Time GCP’s Key Takeaways from CDISC TMF Interchange

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 […]

Just In Time GCP Continues to Grow its Business and Technology Solutions at Veeva Summit

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 […]

Five Key Elements for a Successful Systems Implementation

In the last 2 years at JiT I have been a part of various system implementations in many ways. I have been part of the vendor selection process, the sponsor/lead, the SME, supported migration loaders, performed validation activities, and of course I’m an end-user. So, from all those various roles and experiences in my past, […]

For the 3rd Year in a Row, Just in Time GCP Makes the Inc. 5000, Ranking No. 2813

PHILADELPHIA, August 16, 2023 ( – Inc. revealed today that Just in Time GCP ranks No. 2813 on the 2023 Inc. 5000, its annual list of the fastest-growing private companies in America. The prestigious ranking provides a data-driven look at the most successful companies within the economy’s most dynamic segment—its independent, entrepreneurial businesses. Facebook, Chobani, Under […]

Right-sizing a Clinical Compliance Program

Right-sizing a clinical compliance program in a small pharmaceutical company requires careful consideration and strategic planning. While the specific details will depend on the size and nature of your organization, there are some general steps to help you right-size your clinical compliance program. Start with the basics by familiarizing yourself with the applicable regulations and […]

An Inspection Ready versus Inspection Prepared TMF

I am so ready for a vacation! How many of us have said that daily – ready for and desperately needing a getaway. It is easy to say we are ready for vacation, but would we be prepared for a vacation if it was offered on short notice? Being ready and excited for a vacation […]