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About Just In Time GCP
We leverage innovation to ready your clinical systems and processes for GCP regulatory inspections
Who We Are
Our Story
Just In Time GCP is dedicated to enhancing the quality of clinical trials. JiT GCP is based out of Warrington, PA, founded by Donna Dorozinsky, a second-generation entrepreneur with deep roots in the local business community. JiT GCP achieved remarkable recognition in 2024, landing on the Inc.5000 fastest-growing private companies list for four consecutive years. This prestigious accolade highlights rapid growth and resilience.
Specializing in GCP compliance and inspection readiness, Just In Time GCP partners with small and mid-sized companies to navigate the complexities of clinical trials. JiT GCP tailors risk assessments and operational strategies to meet the unique needs of each client, ensuring their systems and operations are prepared and ready for regulatory inspections. A commitment to exceptional customer service is at the core of our success.
Donna’s journey into entrepreneurship was inspired by her family’s legacy of resilience and innovation. With a background in nursing and extensive experience in the pharmaceutical industry, she established Just In Time GCP as a consulting firm to achieve a better work-life balance. Today, the company employs over 100 professionals across the United States, fostering a family-oriented culture that reflects Donna’s values. Read more Donna’s story as a local innovator in this phillyburbs article.
Just In Time GCP thrives by prioritizing innovation and operational excellence, empowering clients to advance clinical research and accelerate effective treatments for patients.
Our Leadership Team
Donna Dorozinsky
Founder & CEO, Just in Time GCP
As the Founder and CEO of Just in Time GCP, Donna is responsible for running all facets of the business. She is a Registered Nurse and business consultant who has spent over 30 years in drug development with extensive experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her vast experiences dealing with small to large Pharma and biotech companies, academic centers, regulatory agencies, CROs, and investigator sites provides her with the knowledge to assist research organizations in all areas of clinical compliance. She is a member of the TMF Reference Model Steering Committee, a member of Association of Women Entrepreneurs, and honored to be a Founding member of Society of Nurse Scientists, Innovators Entrepreneurs, & Leaders. Donna serves on the Board of Trustees at Gwynedd Mercy University where she received her BSN and also has an MSN from Widener University. Donna is a frequent presenter at conferences and workshops speaking on topics related to Clinical Compliance, Inspection Readiness, and TMF management.
Brian Guza
COO, Just in Time GCP
As Chief Operating Officer at Just in Time GCP, Brian is responsible for leading the execution of the strategic vision and growing the organization’s presence in the industry.
A seasoned healthcare executive with nearly three decades of experience in healthcare operations, strategic planning, technology, and executive leadership, Brian brings his unique pharma service partner experience and insights to help empower Just in Time GCP to better serve its clients and shape the future of this growing company.
George Lyon
Chief Commercial Officer, Just in Time GCP
George Lyon serves as the Chief Commercial Officer at Just in Time GCP, bringing over 30 years of experience in strategic sales, team building, and commercial transformation. A highly driven leader known for his visionary thinking, George has a proven track record of building high-performing teams and driving multi-million dollar revenue growth across global markets. His expertise in formulating and executing corporate strategies with operational excellence positions Just in Time GCP for continued success in the clinical research industry.
Aaron Grant
Head of Innovation, Just in Time GCP
As Head of Innovation at Just in Time GCP, Aaron spearheads efforts to integrate advanced technologies and streamline processes in clinical operations. With over 20 years in regulatory and clinical research technology, he is dedicated to enhancing operational quality through strategic automation and solutions. An active contributor to the CDISC TMF Reference Model Committee, Aaron has driven industry-wide improvements in standardization and quality, bringing a forward-thinking approach to persistent challenges in clinical research. At Just in Time GCP, he is committed to delivering impactful solutions that ensure clients are equipped with the most effective tools, technologies, and techniques for maintaining GCP compliance.
Jennifer Stamper
Director, TMF Services, Just in Time GCP
As a Director of TMF Services at Just in Time GCP, Jenn’s focus is on the Trial Master File (TMF) through TMF management, oversight, and inspection readiness activities. Jenn has a passion for leading people and fostering their career growth within the industry. She started her career in clinical research at a large CRO where her career grew to lead a department of 150+ employees, supporting over 750 active projects with paper and electronic TMFs through migration, set-up, maintenance, quality and delivery of the Trial Master File. Over the past five years, Jenn has supported clients in N.A., EPA, and APAC through EMA, MHRA and FDA inspections. She is actively involved with the TMF Reference Model Working Groups, attends industry conferences and has presented on panels at eXL events. Serving as a member of the leadership team with Just in Time GCP, Jenn’s focus is on the continued growth and development of our company, inspection readiness strategy and supports new business through marketing activities and fostering partnerships.
Carol Radwanski
Director, TMF Services, Just in Time GCP
In her current role as a Director of TMF Services, Carol has made significant contributions to the services team. Carol is a Registered Nurse and began her research career at a Phase 1 Clinical Research Unit. Joining JiT in 2017, some of Carol’s key roles involves providing client support in all aspects of trial master file (TMF) management, including periodic reviews, quality checks, migrations, and audit support. To support professional development, Carol encourages her team to reach their fullest potential and actively supports their growth and knowledge expansion. She regularly attends industry conferences to stay current and help JiT maintain a strong presence in the research community. Carol’s dedication to excellence and collaboration is essential in driving forward clinical research initiatives.
