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With a passion for driving inspection readiness and GCP compliance, we turn your operational challenges into operations excellence

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Is Your Study GCP Inspection Ready?
Are Your Partners Doing What They Say They Are Doing?
What Don’t You Know About Your Study’s Quality?
Are Your Clinical Processes and Systems Ready for Inspections?

Featured Services

Quick Projects with Deep Impact

GCP Gap Assessment

- Assessment of existing procedural documents, related materials, and actual workflows that support study conduct - Gain an understanding of current GCP operating environment, including a high-level review of relevant TMF content - Identification of GCP compliance gaps against regulations and industry best practices, with recommendations for remediations

TMF Story Of The Study

- Review TMF documentation of sponsor oversight and critical activities to identify inconsistencies between study plan requirements and TMF content - Identify gaps against requirements from relevant Study Plans, SOPs, regulations, and best practices - Identify systemic gaps and risk areas - Resulting in an actionable log of identified issues with recommendations to achieve GCP inspection readiness

Clinical Process Capability Assessment

- Comprehensive assessment of clinical processes, systems, and infrastructure to ensure they align with regulatory requirements and resourcing structures/limitations - Insights into implementing a proactive approach to GCP compliance by optimizing procedures

TMF Current State / Future State Roadmap

- Comprehensive evaluation of TMF system functionality and processes - Comparative assessment of current functionality and processes to ideal future state system functionality and processes - Resulting in a future state roadmap that it right-sized to your organizational goals and strategies

TMF Health Assessment

- A comprehensive analysis of TMF content focusing on the following areas - Timeliness surrounding artifact processing and review of audit trails - Quality of TMF content, availability, and ease of navigability - Completeness of the TMF identifying gaps, content relevance, and accuracy of filing.

Site Inspection Preparation

Ensure all documents (protocols, consent forms, IRB approvals) are complete, organized and up to date - Conduct training of site staff on GCP, roles during inspections, and how to interact with inspectors - Execute mock inspection to identify and address potential issues before actual inspection - Ensure the physical site is organized, with proper storage of investigational products and easy access to records.

Not Sure What You Need?

Managed Services is a flexible and expedited offering that requires limited contracting. Decide on a fixed amount of hours with actual scope to be determined and aligned, based on need with ad-hoc requests.

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From Our Customers

Let us empower you with confidence in your GCP inspection readiness

After finding a compliance concern with our trial master file, (TMF), Just in Time GCP was recommended as a specialist. We worked with Donna and her team to create TMF maps, plans, processes, and training, for a complete TMF migration, and as a result, we sailed through our last Health Authority inspection.

The Just in Time GCP team meticulously addressed every detail to ensure our inspection readiness. They conducted a comprehensive TMF gap analysis, assisted in developing storyboards, prepared our subject matter experts (SMEs), and audited our sites. As a result, we successfully completed two mock FDA inspections and now feel confident in our overall inspection readiness.

News You Can Use

Generative AI and Clinical Inspection Readiness

Pondering The “What Ifs” Of Inspection Readiness with Generative AI Just in Time GCP’s Founder and CEO, Donna Dorozinsky, contributed a guest column for Clinical Leader outlining the impact of generative AI on GCP inspection readiness. She describes it’s transformative potential and how to prepare your clinical trials today for adoption and integration. Key Highlights Understanding Generative AI: An overview of the capabilities and benefits of generative AI in regulatory inspections. Navigating Complexities: Insights into the challenges organizations face in adopting this technology. Strategic Implementation: Best practices for integrating AI

TMF Trends from 2024

Clinical Trial Master File Trends from 2024 As we approach 2025, the Clinical Trial Master File (TMF) landscape is undergoing substantial transformations driven by technological advancements and evolving regulatory requirements. At Just in Time GCP, we work with TMFs of all shapes and sizes, and this year, we have identified several clear trends that will significantly impact TMF management. Increased Adoption of Electronic TMF (eTMF) Systems The transition to electronic TMF (eTMF) systems is gaining traction, driven by several key developments: Cloud-Based Solutions: An increasing number of clinical trials are

Welcome George Lyon as Chief Commercial Officer

Just in Time GCP Welcomes George Lyon as Chief Commercial Officer Just in Time GCP is excited to announce the appointment of George Lyon as our new Chief Commercial Officer. “Excited to welcome George Lyon as Chief Commercial Officer at Just in Time GCP! George brings a wealth of expertise in business development and strategic growth, and his leadership will be instrumental as we expand our footprint in the industry. With George at the helm of our commercial strategy, we’re poised to forge new partnerships, drive innovation, and deliver

Generative AI

Generative AI: Innovating Inspection Readiness and TMF Quality As your partner in clinical trials, we at Just in Time GCP understand the challenges of maintaining inspection readiness, especially regarding the quality and completeness of Trial Master Files (TMFs). With the integration of Generative AI into clinical trial management, we are dedicated to helping our clients harness innovation to navigate these complexities. The upcoming digitized Version 4 of the CDISC TMF Reference Model is a significant advancement in this area. Our JiT team members, including Donna Dorozinsky, Aaron Grant, and Kathleen