Home - Just In Time GCP

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

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

Employee Spotlight – Ralf Brooks

The Just in Time GCP Team At Just in Time GCP (JiT), our team members are integral to our mission of delivering top-tier GCP compliance and clinical research consulting services. This month, we’re shining the spotlight on one of ours, Ralf Brooks, who joined the JiT Team just four months ago, in July of 2024. Ralf’s expertise in Good Clinical Practice (GCP) compliance, quality management systems, and clinical research continues to enhance our clients’ success. Why did you decide to work at Just in Time GCP? “I joined JiT

Insights from the 2024 Veeva R&D and Quality Summit

Insights from the 2024 Veeva R&D Summit Last week the Just in Time GCP team attended the Veeva R&D Summit in Boston where we proudly served as a Gold Sponsor. Veeva Summit was an exciting experience which provided an opportunity for attendees to engage with Veeva experts, partners, and users. It also offered a glimpse into the future of Veeva’s innovations and the evolving landscape of clinical operations. A recurring theme of this year’s summit was to ‘Simplify and Standardize’. Veeva leaders shared their vision of how we can achieve

The Recent FDA Draft Guidance on Processes & Practices Applicable to a BIMO Inspection

“Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry” is a draft guidance document issued by the FDA in June of this year. The intent is to provide clarity on the procedures and practices related to Bioresearch Monitoring (BIMO) inspections. This document is designed to help industry stakeholders understand what to expect during FDA inspections of sites and facilities involved in FDA-regulated research, ensuring compliance with statutory requirements and safeguarding the integrity of data and the welfare of clinical trial participants. It provides critical insights for industry stakeholders

Just in Time GCP Celebrates Its Fourth Consecutive Year on the Inc. 5000 List!

Just in Time GCP is proud to announce its inclusion on the 2024 Inc. 5000 list, marking the fourth consecutive year the company has been recognized among America’s fastest-growing private companies.  “This achievement is a testament to the hard work the incredible JIT GCP Team has put in over the past several years, and the remarkable journey we are taking together.” says Founder & CEO Donna Dorozinsky. The Inc. 5000 list is a prestigious ranking that highlights the most successful independent businesses in the U.S. The 2024 list showcases