Just in Time GCP

Your path to inspection confidence.

Modern Compliance Solutions for Complex Clinical Trials

For over 20 years, Just in Time GCP has empowered trial sponsors with inspection-ready confidence

View Our Most Popular Services—And Why They Matter

How We Get You There

ASSESSMENT

ROADMAP

OPTIMIZATION

SUPPORT

Providing the Answers You Need

  • Could you confidently walk a regulatory inspector through your trial oversight—today?
  • Do you have clear visibility into CRO and partner performance, or are gaps surfacing too late?
  • Was your TMF designed to support inspection readiness, or simply to store documents?
  • Are your clinical systems helping you identify risk and trends—or adding complexity without insight?
  • Do your SOPs reflect how your trials operate now and withstand real regulatory scrutiny?

5 Reasons To Choose Just in Time GCP

TRUSTED PARTNER

Over 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.

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 2025 Inc. 5000 Fastest-Growing Private Companies list for the fifth 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 60 full-time, U.S.-based clinical professionals, united in their mission to help partners deliver effective treatments to those in need.

What Our Partners Say

"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."
Director, Clinical Operations Small Pharma Company
"The value Just in Time GCP provided through our TMF audit, is impossible to put a price on."
Clinical OperationsSmall Pharma Company
“We sailed through our last Health Authority inspection.”
VP, Clinical OperationsMid-Sized Pharma Company
“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.”
Clinical Records ManagementSmall Biotech
"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."
Clinical OperationsEmerging Pharma
"Just in Time GCP doesn't just check the boxes—they genuinely care about our success."
Senior Director, TMF OperationsSmall Biotech Company
“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.”
Clinical Operations LeadSmall Pharma
"The people at Just in Time GCP feel like an extension of our team. I absolutely trust them."
Senior Director, Clinical SystemsMid-Sized Biotech Company
"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."
Return ClientSmall Pharma

Why Industry Leaders Trust Just in Time GCP

  • Over 60 Full-Time Employees
  • 100% U.S.-Based Operations
  • Certified Women-Owned Business
  • Accuracy Rate Exceeding 97% in Records Processing
  • Veeva White Belts On Staff
Veeva Badge - Preferred Services Partner for Development Cloud

GCP Inspection Ready. Set. Go.

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