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

We customize and adapt solutions that fit your budgets and timelines

Let Us Help You Answer….

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 eClinical Systems Prepared for Regulatory Inspections?

What We Offer

Our Services

Quality Management System

A quality management system is the cornerstone of the drug development program. Procedural documents serve as the foundation of a QMS supported by training and audit. We support our clients in developing efficient and realistic process and then develop the procedural documents, training materials and conduct audits.

TMF Management

We take the stress out of TMF management and assist your organization in harnessing the power of a complete TMF. We can support you through all steps of the process, from identifying a system, through validation and implementation of the system and supporting processes. Once fully implemented, we can support you with TMF management services.

GCP Audits

Whether your needs are driven by inspection preparation or ongoing clinical compliance oversight, our auditors will identify compliance issues or areas for improvement. Our team can then work with you to help achieve site and vendor compliance in addressing these issues.

Site Operations

We assist sites in implementing Quality Management Systems and optimizing existing processes.

Sponsor Services

Our clinical operations team works with organizations in developing and implementing process that supports quality operations and sponsor oversight activities. We will review current processes, identify gaps, and provide suggestions for new processes or steamlining current processes.

Inspection Readiness

We ensure your organization, vendors, and sites are inspection ready. Our indepth review of TMF content identifies inspection risks before the inspection and assists you in developing story boards to support the inspection. Our team will help get your TMF inspection ready, prepare your organization for the inspection, and then support you during the inspection.

Training

We provide training for your clinical operations team and our programs are customized to meet your needs.

Explore Our Services

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

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

Welcome Aaron Grant as Head of Innovation

Just in Time GCP is thrilled to announce the appointment of Aaron Grant as the new Head of Innovation, a newly created position designed to drive change within the clinical research industry. With a strong passion for industry transformation and a commitment to excellence, Aaron brings extensive experience and a forward-thinking mindset to the Just in Time GCP team. Must Consistently Raise Standards to Drive Excellence “Just in Time GCP is a highly regarded authority on best practices in clinical research; however, it’s essential to recognize that the definition of