About Just In Time GCP

Leaders in Clinical Compliance, Inspection Readiness & Operational Clarity

Who We Are

Our Story

At Just in Time GCP, we believe compliance shouldn’t slow progress—it should enable it. It should create the structure, visibility, and control needed to confidently execute clinical trials and stand up to regulatory scrutiny.

Founded in 2005 by Donna Dorozinsky, our company was built to help clinical teams meet regulatory expectations while maintaining operational momentum and quality. Today, we are a national team of over 60 experts supporting trials across all phases and therapeutic areas.

We are known not only for clinical compliance, but for helping sponsors achieve true inspection readiness and operational clarity. Our clients—from emerging biotechs to large pharma—come to us for a more structured, confident path forward.

Our work spans TMF oversight, inspection readiness, process optimization, and system enablement. We bring clarity to complexity, strengthen oversight, and ensure compliance, quality, and execution work together.

For over 20 years, we’ve partnered with trial sponsors to move forward with confidence—knowing their trials are not only compliant, but controlled, optimized, and ready for inspection.

Leadership

Donna Dorozinsky

Founder & CEO, Just in Time GCP

Donna Dorozinsky began her career as a clinical nurse and turned that hands-on experience into a decades-long mission to improve clinical research. Today, as Founder and CEO of Just in Time GCP, she leads one of the industry’s most trusted clinical compliance companies—helping sponsors simplify GCP, manage TMFs with confidence, and stay inspection-ready across complex global trials.

With over 30 years in drug development, Donna has partnered with biotechs, pharma, CROs, and academic sites—building relationships that span not just projects, but careers. Her clients often bring her along as they move from company to company, a testament to the trust and value she delivers.

She’s known for her deep operational expertise across TMF, eClinical systems (eTMF, CTMS, QMS), and clinical quality frameworks—always combining innovation with practical, people-first solutions.

Lead Editor, Good Clinical Practice: A Q&A Reference Guide (2024/2025, 2026/2027)
TMF Standard Model (fka The TMF Reference Model) Steering Committee Member
Ernst & Young Entrepreneur of the Year 2022
Just in Time GCP, named to the INC5000 list five years running

Donna holds a BSN from Gwynedd Mercy University—where she now serves on the Board of Trustees—and an MSN from Widener University. She’s also a founding member of SONSIEL, where nurse leaders drive innovation across healthcare. Above all, Donna is driven by a passion for lasting impact—on teams, on trials, and on the future of clinical research.

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.

Alycia Hannum

Director, Human Resources, Just in Time GCP

As Human Resources Director at Just in Time GCP, Alycia is responsible for shaping and implementing people-focused strategies that support the company’s mission and empower employees to thrive. Passionate about fostering a culture of collaboration and continuous growth, Alycia leads initiatives in organizational development, employee engagement, and talent acquisition. Since joining Just in Time GCP in 2023, her efforts have been instrumental in building a strong, inclusive workplace where employees feel valued and inspired to reach their full potential.

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.

Greg Tietjen

Consulting Practice Lead, Just in Time GCP

As a Consulting Practice Lead at Just in Time GCP, Greg Tietjen provides structure, clarity, and control to complex clinical programs, strengthening GCP compliance, inspection readiness, and operational effectiveness.

Greg brings extensive experience leading global, cross-functional initiatives across clinical, regulatory, safety, quality, and commercial domains. Prior to joining Just in Time GCP, he served as a Global Program Manager at Veeva Systems, leading enterprise implementation, adoption, and governance across the Vault platform. Earlier in his career, he held senior roles at Bristol-Myers Squibb and Merck, and began his consulting career at Accenture, driving strategic initiatives in information management, data architecture, and R&D innovation.

He specializes in translating complex strategies into structured, executable delivery—designing cross-functional programs, establishing scalable governance models, aligning stakeholders, and driving technology-enabled transformation in highly regulated environments.

At Just in Time GCP, Greg focuses on advancing delivery excellence, strengthening client partnerships, and applying systems thinking to improve how organizations plan, execute, and scale clinical programs, with a growing focus on AI-driven productivity.