Simplify GCP Compliance,
Amplify Clinical Success
Innovative GCP Compliance through Clinical Technology and Business Process Optimization
For over twenty years, Just in Time GCP has empowered our partners with clinical compliance confidence. We help you align people, processes, and technologies with Good Clinical Practices and your unique organizational goals, enhancing study success and providing peace of mind.
Our expertise covers all aspects of GCP compliance, supported by a team of over 100 full-time clinical experts. We stay current with new regulations, innovative technologies, and industry best practices so you don’t have to. Whether you need assistance with an upcoming inspection, a system/TMF implementation issue, SOP creation, partner oversight, asset acquisition, ongoing support, immediate remediations, or a quick quality assessment, we are here to help.
Providing the Answers You Need
- Is your study prepared for an upcoming regulatory inspection?
- Are your clinical partners fulfilling their commitments?
- Was your TMF implemented for optimum efficiency?
- Are you maximizing the utility and value of your clinical systems?
- Do you have all the necessary SOPs in place to ensure clinical compliance?
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. The family-oriented culture at Just in Time GCP reflects Donna’s values and commitment to fostering a supportive workplace.
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 Confidence
Expertise
The Just in Time GCP team is passionate about advancing clinical research and influencing industry change.
Risk-Based Quality Management
Implementing Risk-Based Quality Management: Insights from the Latest GCP Guide The 2024/2025 edition of Barnett’s Good
Driving Growth at Just in Time GCP
George Lyon Joins Just in Time GCP to Drive Commercial Growth Just in Time GCP is
The CDISC TMF Reference Model at Small Companies
Why the CDISC TMF Reference Model is Important for Smaller Companies Executing Clinical Trials If you’re
Why Industry Leaders Trust Just in Time GCP for Their Clinical Compliance Needs
- Over 115 Full-Time Employees
- 100% U.S.-Based Operations
- Certified Women-Owned Business
- Accuracy Rate Exceeding 97% in Records Processing
- Four Veeva White Belts On Staff
GCP Inspection Ready. Set. Go.
