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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?

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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

ICH E6(R3) Release – Aligning Clinical Processes

ICH E6(R3) Finalization – An Action Plan for Clinical Compliance Critical Impacts of ICH E6 (R3) and Business Process Updates for Clinical Trial Sponsors The release of ICH E6 (R3) ushers in a new era of clinical trial management, focusing heavily on risk management, quality by design, and enhanced oversight. While the updated guidance emphasizes principles, its implementation requires sponsors to translate these into actionable business process updates. Below, we outline practical examples of how sponsor organizations now need to adapt their processes to align with ICH E6 (R3).

Hidden TMF Clinical Compliance Risks

Hidden TMF Clinical Compliance Risks Inspectable Content Housed OUTSIDE the TMF In the fast-paced world of clinical trials, maintaining a robust and compliant Trial Master File (TMF) is essential for inspection readiness. Yet, many sponsors inadvertently overlook critical TMF content that they generate during the trial, only to scramble for it during preparation for regulatory inspections or asset transfers. This oversight can create unnecessary stress and risk for organizations. The TMF is defined as the collection of records that show that the trial is being conducted to regulatory requirements. This

20 Years of Clinical Compliance Excellence

20 Years of Delivering Clinical Compliance Confidence Founded in 2005, Just in Time GCP has empowered our partners with clinical compliance confidence for over 20 years. We align people, processes, and technologies with Good Clinical Practices (GCP) and your unique organizational goals, enhancing study success and providing you with peace of mind. Simplify GCP Compliance, Amplify Clinical Success Our team of over 100 full-time clinical experts offers comprehensive GCP compliance support, including: Upcoming inspection assistance System implementation solutions SOP creation Clinical oversight Asset acquisition Ongoing support Immediate remediations Quick quality

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