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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.

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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

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

Clinical Process Assessment

Ensuring Your Operations Support Your Trial’s Scope Moderating a recent roundtable discussion on clinical process assessment has highlighted a growing gap between current clinical process capabilities and the requirements needed to execute complex studies. A comprehensive assessment of clinical processes, systems, and infrastructure is essential to ensure they align with both regulatory requirements to ensure compliance and resourcing structures/limitations. This type of evaluation provides trial sponsors with vital insights to standardize a proactive approach GCP compliance by optimizing procedures. What Could Happen if There Is Misalignment? Compromised Data Integrity Regulatory

Insights on TMF Management

The Importance of TMF Management in Clinical Quality Just in Time GCP’s Founder and CEO, Donna Dorozinsky, shared her expertise in a recent article in The Clinical Trial Vanguard titled The Trial Master File: A Window into the Quality of Any Clinical Study. This article highlights the essential role of the Trial Master File (TMF) in ensuring the quality, compliance, and integrity of clinical trials. Key Insights on Study Quality from TMF In the article, Donna discusses several critical aspects of the TMF and the potential quality implications if they

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