Your path to inspection confidence.

Modern Compliance Solutions for Complex Clinical Trials

The stakes are too high to let compliance challenges slow you down.

For over twenty years, Just in Time GCP has empowered trial sponsors with
inspection-ready confidence.

Grounded in our commitment to quality and innovation, we align people, processes, and technologies with both regulatory standards and each organization’s unique goals.
Through collaboration and forward-thinking strategies, we deliver peace of mind—ensuring trials are
inspection-ready today and prepared for the challenges of tomorrow.

Providing the Answers You Need

Your Journey to GCP Compliance Starts Here

ASSESSMENT

ROADMAP

OPTIMIZATION

SUPPORT

Our Story

Just In Time GCP, founded in 2005 by Donna Dorozinsky in Warrington, PA, is an SBA-certified women-owned business led by a second-generation entrepreneur deeply rooted in the local community. Under Donna’s leadership over the past 20 years, the company has garnered significant recognition, appearing on the 2024 Inc. 5000 Fastest-Growing Private Companies list for the fourth consecutive year, showcasing its rapid growth and resilience.

Just in Time GCP thrives by prioritizing innovation and operational excellence, empowering clients to advance clinical research and accelerate effective treatments for patients. Today, the company employs over 100 full-time, U.S.-based clinical professionals, united in their mission to help partners deliver effective treatments to those in need.

5 Reasons To Choose Just in Time GCP

TRUSTED PARTNER

Twenty years of delivering clinical excellence and passionate leadership influencing industry change, have earned Just in Time GCP the industry’s trust and respect.

Personalized Services, Extensive Resources

We listen to your unique challenges, give you the personal attention you deserve, while sourcing from our deep rooted network of resources and experts to identify the right solution for you.

Customizable and adaptable solutions

We’ll create a solution specifically designed to fit your budget, needs and timelines.

Scalable services long-term partnerships

You’ll be able to ramp services up or down as your specific needs change.

UNPARALLELED EXPERTISE

We leverage knowledge from over 400 completed projects, supported by a team of 100 full-time, U.S.-based clinical experts with experience in more than 100 regulatory inspections across diverse company types and sizes.

Let Us Empower You With Compliance Confidence

"Just in Time GCP's review not only improved the completeness of that study's TMF—it also strengthened documentation quality across our entire portfolio."

"The value Just in Time GCP provided through our TMF audit, is impossible to put a price on."

“We sailed through our last Health Authority inspection.”

“The business relationship has been professional, knowledgeable, cordial, and collaborative. Ideas are openly shared, honest feedback is encouraged, and conversations are both transparent and productive.”

"The Just in Time GCP team was great at following up with us, extremely professional and very accessible. I really appreciated that it was a true collaboration."

"Just in Time GCP doesn't just check the boxes—they genuinely care about our success."

“Just in Time GCP helped us identify gaps to ensure a complete study TMF. Their insights extended well beyond the initial scope and were applied across other countries, sites, and trials.”

"The people at Just in Time GCP feel like an extension of our team. I absolutely trust them."

"Just in Time GCP is flexible, dependable, and knowledgeable. The team is easy to work with and provides thorough explanations and examples of corrective actions."

Expertise

The Just in Time GCP team is passionate about advancing clinical research and influencing industry change.